Coordinator, Regulatory Resume Samples
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Coordinator, Regulatory Resume Samples
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DK
D Kling
Don
Kling
6265 Hortense Fields
Philadelphia
PA
+1 (555) 715 5376
6265 Hortense Fields
Philadelphia
PA
Phone
p
+1 (555) 715 5376
Experience
Experience
Detroit, MI
Coordinator, Regulatory Compliance
Detroit, MI
Rutherford-Ryan
Detroit, MI
Coordinator, Regulatory Compliance
- Administration of the matter management system and internal shared drive in their use as the department’s document management system
- Perform periodic self-managed audits to confirm data integrity of system
- Create documentation and procedures to scale and improve compliance efficiency
- Actively work across the organization to ensure all contributors are working in compliance with federal regulations
- Provide training, when necessary, to new and established users. Serve as primary Point of Contact for questions & issues related to the system
- Evaluate controls are in place to successfully track all pending items and develop processes to improve efficiency of system, where necessary
- Manage one-off projects and licensing expansions
Philadelphia, PA
Technical Coordinator, Regulatory Reporting
Philadelphia, PA
Leuschke, Mohr and Rice
Philadelphia, PA
Technical Coordinator, Regulatory Reporting
- Work closely with the Team Leader and Section Manager for on-boarding new transitions and staff
- Identify and implement process improvements to reduce risk and develop efficiency of function
- To assist with training and coaching of new team members
- Perform quality assurance checks on the reports prepared by junior members in the team before delivering to Home Location
- Ensure all scheduled work is completed by agreed deadlines, checklists are signed and files are complete
- Point out issues/exceptions observed and resolved these accordingly with Home Location’s assistance
- Work closely with counterparts in home locations to resolve queries
present
Phoenix, AZ
Registered Nurse Regulatory Compliance Coordinator
Phoenix, AZ
Hirthe and Sons
present
Phoenix, AZ
Registered Nurse Regulatory Compliance Coordinator
present
- Employs performance improvement/system redesign methodologies and strategies to facilitate continual compliance and optimal performance
- Provides direct staff assistance to the Director and Quality Management in the coordination and preparation for various external surveys, audits and reviews
- Increases staff awareness of accreditation standards and assists staff in any areas of opportunity to improve
- Participates in the establishment and review of pertinent policies and procedures
- Compiles and analyzes data, related to continual regulatory compliance, prepares reports and presents findings and recommendations to leadership and staff at all levels in the organization. Areas of concern are immediately brought to the attention of the Quality Management Director
- Oversees ECHCS policy management
- Serves as a resource to clinical and administrative leaders in the interpretation and application of accreditation, Veterans Health Administration (VHA), local and professional standards and guidelines (i.e. TJC standards & other regulatory standards, VHA Directives, etc)
Education
Education
Bachelor’s Degree in Nursing
Bachelor’s Degree in Nursing
Quinnipiac University
Bachelor’s Degree in Nursing
Skills
Skills
- Attention to detail; strong writing skills
- A positive attitude with an ability to work proactively and prioritize
- Ability to communication remotely with team members across the country
- Good sense of humor
- Strong organizational skills
- Strong business partnering skills
- The ability to work well independently as well as part of a team
- Willingness to embrace frequent change in all forms
- Gets stuff done
15 Coordinator, Regulatory resume templates
Read our complete resume writing guides
1
Cro Regulatory Self Assessment Coordinator Resume Examples & Samples
- Setting up the self-assessment templates including identifying the relevant rules for the legal entities in scope, categories of compliance, reporting date, and primary owners
- Coordinating the response to each rule with the primary owner, including collecting the response, assisting with drafting, providing quality assurance reviews of the response, reviewing all responses for internal consistency
- Setting up Quality Assurance (QA) panels to review rules where Credit Suisse (CS) is not fully compliant or where there are questions over rule interpretation and level of compliance. Taking minutes of QA panels, tracking actions, and checking that any revised responses address QA panel’s actions
- Act as a second line of support for regulatory coordination and advice; expected to develop a strong knowledge of current and planned regulation, and risk management in one of the key risk areas, e.g. market, credit, counterparty, operational, or Pillar 2
- Support the Head of CRO Regulatory Compliance in project planning and resourcing
2
Mutual Funds Regulatory Administration Coordinator Resume Examples & Samples
- 5+ years of experience in the Legal and/or Securities industry; paralegal experience preferred but not required
- Knowledge of asset management business, particularly with respect to investment companies and related service providers
- Demonstrated analytical abilities
- Excellent computer skills in Windows-based software products such as Word, Excel and Outlook
- Demonstrated proficiency in PowerPoint
- Excellent organizational skills and strong attention to detail
- Self-starter who works well under pressure to meet deadlines
- Ability to simultaneously manage multiple time sensitive tasks
- Interpersonal skills and ability to develop effective working relationships
- Ability to work independently as well as within a team and across the organization
- Paralegal Certification
3
Regulatory Request Coordinator Resume Examples & Samples
- Act as a central point of contact for cyber security related regulatory surveys, questionnaires, inspections and related preparation work for internal and external IT audit engagements
- Coordinate the collection of information with global TSS teams to ensure validity and accuracy of information for submission
- Provide oversight to ensure timely response on regulatory / audit requests for APAC
- Act as central point of contact for global TSS projects having an impact or an APAC specific requirements
- Establish and maintain close working relationships within the global TSS teams (e.g. audit, project management, engineering, operations, etc.), APAC IT Risk and regional management
4
Regulatory Liaison Coordinator Resume Examples & Samples
- Responsible for coordinating the enterprise-wide regulatory activities associated with the Bank’s regulators
- Develop and maintain effective working relationships with regulatory agencies and management
- Create and implement organizational policies, standards and procedures for the Regulatory Affairs Team
- Establish effective communications with stakeholders to keep all relevant parties informed of regulatory examinations and results
- Oversee the logistical and administrative support required for effective management and coordination of examinations, including requests for meetings and conference rooms, physical access to buildings, laptops, other equipment and technical assistance
- Coordinate the enterprise-wide responses to all regulatory information requests
- Responsible for gathering and/or developing all information requests from the regulators in the area of Internal Audit
- Participate in meetings between the regulators and management and ensure that all requested actions and deliverables are provided to the regulators in a timely manner
- Responsible for coordinating the Bank’s responses to examination conclusions
- Review proposed action plans developed by management to remediate findings to ensure they are appropriate, timely and realistic
- Accountable for effectively managing the tracking and reporting of regulatory findings. Hold others accountable for 1) escalating issues in a timely manner and 2) adhering to deadlines
- Develop and produce ad-hoc, monthly, quarterly and annual management reports, including data analysis, for executive management and Board Committees
- Contribute to other duties and special projects as assigned
- Bachelor’s degree required accounting, business, or other related field or equivalent work experience
- Four to eight years of relevant experience required
- Compliance, audit or regulatory background a plus
- Track record of cultivating strong relationships with internal and external partners
- Demonstrated ability to think outside-the-box and collaborate with associates at all levels across the Bank
- Outstanding written and verbal communication skills with demonstrated ability to communicate effectively across all levels
- Strong project management skills required, with the ability to effectively manage several projects at once and resourcefulness in terms of mustering the people and enthusiasm needed to define and implement meaningful improvements
- Experience working within a complex, regulated company/industry – experience in banking or financial services preferred and experience working as a banking regulator a plus
- Ability to work well in a multi-task environment under pressure and tight time constraints
- Strong personal computer skills, a working knowledge of Microsoft Word, Excel, Visio or PowerPoint, SharePoint
- A true team player participating on a high quality team of experienced professionals
- Track record of delivering projects on-time
- Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers
- Customer Focus: Is dedicated to meeting the expectations and requirements of “customers” (including both internal and external parties); gets first-hand information from the regulators and uses it for improvements in processes; acts with “customers” in mind; establishes and maintains effective relationships with “customers” and gains their trust and respect
- Results Driven: Can be counted on to exceed goals successfully; steadfastly pushes self and others for results
- Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything
- LI-UP
5
Coordinator, Regulatory & Policy Resume Examples & Samples
- Collect and evaluate information on food standards and nutrition and labeling policy trends on products, ingredients and labeling to facilitate the work of the SRA Regulatory & Policy team
- Maintain and organize records and databases in order to ensure that they are current, secure, and easily retrievable
- Assist in communications to the internal and external stakeholders
- Assist in data submissions to global organizations, regulatory authorities, and governments on products, ingredients and labeling to protect brands and sustain growth
- Excellent written and verbal communication skills needed to effectively communicate with SRA associates and other internal and external multicultural audiences
- Basic Regulatory and Policy Knowledge: General knowledge of the regulatory and food policy landscape (e.g., regulations, issues) that may affect the beverage or food industry. This includes recognition and appreciation of differences in the regulatory framework of different countries as well as some knowledge of the major regulatory and policy issues facing the food and beverage industry
- Databases/Data Acquisition: Knowledge of and ability to use technical databases (e.g., scientific, regulatory). Ability to understand and apply hardware and software used in the collection of technical data in a laboratory or field environment
- Document Management: Ability to create, approve, track and file documents and records in regulatory arena
- Process Improvement: Ability to analyze existing processes and identify more efficient ways to accomplish goals and meet customer and client requirements; ability to continuously improve processes through regular assessment and adjustment
- Ingredients: Knowledge of key ingredients used in production of concentrates and beverage bases (e.g., caramel, citric acid, benzoate, juice, phosphoric acid)
- Product standards: Knowledge of key beverage standards (e.g., juices, nectars, water based flavored drinks)
- Labeling: Knowledge of basic labeling concepts and definitions involved in general food labeling
- Basic Nutrition: Knowledge of basic nutrition concepts and definitions involved in basic nutritional labeling
- Proprietary Composition Information: Ability to recognize and protect proprietary information as it relates to formulas and ingredients
6
Regulatory Self-assessment Coordinator Resume Examples & Samples
- Setting up Quality Assurance panels to review rules where CS is not fully compliant or where there are questions over rule interpretation and level of compliance. Taking minutes of QA panels, tracking actions, and checking that any revised responses address QA panel’s actions
- Providing Management Information to Team head and Senior Risk committees on overall completion of responses, current levels of compliance, remediation plans
- Assisting Senior Management in CRO with their internal reviews of the responses, including putting together summary information packs that can be used for self-attestation by SIFs
- Acting as the central point of contact with internal audit and external audit for any reviews that they perform on the self-assessment
- Manage self-assessment against regulatory changes affecting existing compliance
- Act as a second line of support for regulatory coordination and advice; expected to develop a solid knowledge of current and planned regulation, and risk management in one of the key risk areas, e.g. market, credit, counterparty, operational, or Pillar 2
- LI-MK4*
7
Regulatory Case Coordinator Resume Examples & Samples
- -----------------------
- Two-year college degree or 2 years work-related experience required
- Ability to work effectively in a team environment
8
Regulatory / Safety Coordinator Resume Examples & Samples
- The Regulatory Coordinator/Safety Officer is responsible for coordinating the overall development, implementation and evaluation of the hospital's safety management and regulatory accreditation continual readiness for accreditation programs to successfully meet regulatory/accreditation standards. Within the scope of this work the coordinator consults with leaders and provides guidance for program certification and re-certification
- The Regulatory Coordinator/Safety Officer incorporates the Medical Center mission/goals, while also assisting to enhance a safe environment for patients, employees, visitors and volunteers
- This position works closely with the Employee Health program and serves as the Safety Officer for Cambridge Medical Center and the North Branch/Isanti Clinics. In addition, it will also support Buffalo Hospital in safety initiatives and will be required to work one day a week at Buffalo Hospital (2 shifts a pay period)
9
Regulatory Submission Coordinator Resume Examples & Samples
- Possession of a high school diploma or equivalent
- A minimum of three (3) years of progressively responsible secretarial experience, including one (1) year at the level of Secretary II or equivalent
- Ability to work in a clinical research setting, both independently and within a team
- Ability to compile and maintain regulatory files for Food and Drug Administration (FDA) submissions
- Working knowledge of FDA regulations for Good Clinical Practices (GCP)
- Ability to prioritize multiple tasks/projects through effective organizational and planning skills
- Proficiency in Microsoft software applications (Windows, Word, Excel, and PowerPoint)
- Knowledge of medical terminology and regulatory guidelines
10
Regulatory & Administrative Coordinator Resume Examples & Samples
- Preparing and managing regulatory submissions to the GU IRB
- Generating and maintaining documentation related to research protocol start-up and implementation for clinical trial sponsors and the GU IRB
- Working with the Associate Program Coordinator to develop financial reports, invoicing tools, financial projections of clinical trial income
- Updating MDP website, oversees Facebook page, coordinates production/distribution of Program Newsletter, develop handouts for clinical trials recruitment and retention, and manages events such as the Patient and Caregiver Appreciation Luncheon
- Working with GU Procurement Office to expedite service agreements with external vendors
11
Regulatory Case Coordinator, Senior Resume Examples & Samples
- BA/BS in business, public policy, communications or economics desired
- Previous experience in Law or Regulatory Affairs
- Basic understanding of the regulatory environment
- Strong knowledge of Word, Excel, PowerPoint
- Skilled in using WebDocs, CPUC and FERC websites
- Excellent verbal, written communications skills
- Serves in a lead coordinator role for proceedings of moderate to high complexity or scope. As lead, may direct the work of peers in cases
- Utilizes case expertise by independently resolving issues and conducting basic research and analysis as requested by the case manager
- Supports less structured case teams in meeting case objectives and deliverables
- With minimal supervision, leads and/or coordinates the production, filing, distribution and posting of regulatory documents – including testimony, workpapers supporting testimony, and responses to date requests
12
Regulatory Development Monitoring Coordinator Resume Examples & Samples
- Managing all aspects of the routine Regulatory Development Monitoring (RDM) calls between local GCO and Compliance teams, including
- Proficient in one or more other European languages (desirable)
- Familiarity with commercial legal, risk or compliance environment (preferred)
- Keen interest in legal developments, particularly in financial services. Ideal Personal Attributes
- Close attention to detail and strong administrative, planning and organisational skills
- Strong, intellectual curiosity, creative thinking and resourcefulness
- Good team player who is able to build a network of positive relationships with teams in a number of countries
- Professional, customer-centric work ethic
- Self-starter who is motivated to persevere to drive the right results
- Able communicator who is able to discuss RDM’s work with people at all levels of the GCO
- Cultural sensitivity and positive attitude to change
13
Coordinator Regulatory Compliance Resume Examples & Samples
- Customer Service experience preferred
- Successful completion of mandatory off-site Ground Security Coordinator and other required training
- Excellent interpersonal skills with ability to interact effectively at all levels, both internally and externally
- Proven skills in organizing and managing time across multiple tasks
- Ability to sit, stand or walk for prolonged periods of time
- Must work well under deadlines and high volume stress periods
- Ability to handle multiple tasks and adapt to constant changes while working with minimal supervision
- Reports to work on a regular and timely basis
14
Regulatory Research Coordinator Resume Examples & Samples
- Bi-lingual (Spanish) preferred. Familiarity with Clinical Data Management Systems such as RAVE, DATATRACK or ORACLE. Preferred
- Clinical research experience. Understanding or prior experience with Institutional Review Boards and Food and Drug Administration. Preferred
- Bachelor's degree in science or a healthcare-related field. SOCRA certification Preferred
- Experience with Microsoft Word, Excel and Access
- College-level reading ability
- Attention to detail and deadline requirements
- Ability to read and understand research protocols
- Ability to effectively communicate and interact with staff, and physicians
- Ability to effectively work with external pharmaceutical companies and other potential research resources
- Demonstrated ability to motivate others to achieve goals
- Demonstrated ability to lead others in difficult situations
- Strong problem solving skills, ability to manage project tasks and timelines, and analytical ability
- Ability to work with and communicate to a diverse work force in all levels of the organization
15
Coordinator, Quality & Regulatory Audit Resume Examples & Samples
- Demonstrates comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques
- Analyzes regulatory requirements and overall program compliance to determine enterprise risk
- Proposes and/or implements audit program enhancements
- Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation
- Communicates best practices observed to other business units
- Prepares for audits by researching materials, standards, policies and procedures to formulate a plan of action
16
Senior Coordinator Regulatory Submissions Operations Resume Examples & Samples
- Assists publishers with tasks, such as pre-publishing (formatting, bookmarking, hyperlinking) and QC
- Uses various systems and tools (i.e. Toolbox (formerly referred to as ISI Toolbox), InSight Publisher, eCTDXpress, etc.) for compilation, formatting, assembly, etc
- Completes work assignments with minimal supervision/guidance and high quality
- Builds regulatory submissions using specified processes, procedures and systems
- Incorporates Quality Control (QC) review comments
- Intermediate knowledge of MS Word
- Basic knowledge of MS Excel
- Minimum of one year in pharmaceutical industry is beneficial
17
Regulatory Self-assessment Coordinator Resume Examples & Samples
- 3+ years of experience preferably in a risk management, internal audit, operational risk, legal and compliance role in an investment or large commercial bank, accountancy/consultancy firm or regulator
- Proven organisation and coordination skills in engaging SMEs, tracking progress and ensuring delivery
- High attention to detail, legalistic mindset, excellent drafting and English comprehension skills
- Ability to challenge quality/consistency of documents
- Ability to communicate clearly and effectively, particularly across cultures and when working remotely
- Proven performance through high academic achievement
- Interest in and knowledge of the risk-related regulatory framework (Basel (II, II.5, III), CRD4/CRR, Market Risk, Op Risk rules etc.)
- Good IT skills, preferably experience with MS Excel, MS Access and MS SharePoint
18
Coordinator, Regulatory Resume Examples & Samples
- Create, organize, manage, and make paper and/or electronic copies of files and documentation including international registrations, technical files, design dossiers, and certificates
- Manage international RA sharepoint site
- Maintain and manage International RA SOPs
- Support the International Regulatory Affairs Department with travel planning
- Support the VP International RA with administrative tasks, such as invoice payment, international travel arrangements, and records keeping
- Bachelor degree with major in engineering or life sciences; equivalent work experience will be considered
- 1-2 years experience in document control in a regulated environment
- Demonstrated ability to use/create databases and prepare documents and presentations
- Ability to multi-task and prioritize assignments
19
Global Regulatory Sciences Coordinator Resume Examples & Samples
- Collaborate with R&D Accounting to harmonize and mesh financial tracking spreadsheet(s) and processes
- Oversee all GRS P-card expenditures and related record-keeping for Director’s approval
- Prepare annual R&D Tax Credit documents to support Accounting and Tax
- Provide general administrative support to GRS Ewing Team, and assist the Director and team Managers as needed for Harrogate and Horsholm staff and facilities
- Maintain office, copier/printer/scanner/FAX machines, laminator, and common area equipment, supplies, maintenance, and support as needed
- Schedule routine and ad hoc meetings as needed by GRS Director and Managers
- Provide general support to Director and Managers for travel arrangements, expense reports, and hosting GRS Ewing visitors
- Create and track status of work orders for facility, office, and safety equipment
- Work with IT to maintain GRS Sharepoint and shared drive documents, libraries, and directories
- Work with Archivist, QAU Manager, and Director to manager paper archives at Iron Mountain and EPL. Be cognizant of Corporate Record Retention Policy
- Create, edit, format, and update various presentations, forms, and spreadsheets to meet team needs using Microsoft® suite of software
- Initiate and support on-boarding process for any new GRS employees
- 10+ years administrative experience supporting senior level management
- 5+ years experience demonstrated experience with financial and legal procedures for external contracting, especially for R&D scientific studies
- Strong skills and expertise in Microsoft® programs – Excel, PowerPoint, Word
- Experience with SAP and financial tracking principles
- Demonstrated ability to work effectively and efficiently within a team environment and support projects from multiple senior managers and scientific staff members
- Position requires a strong collaborative and customer service disposition, able and willing to support and deal with numerous global business departments
- Flexible and adaptable to changing environments with a can-do work ethic, strong attention to detail, and perseverance to take projects from initiation to completion and archiving
- Financial and legal acumen
- Attention to detail, time-focused, and juggling multiple priorities
- Collaboration within multi-discipline team
- Customer focus, integrity, and respect
- Composure, decisive, ability to deal with ambiguity, and capable of working with minimal supervision
- Office safety, travel safety, and asset and document security mindset
20
Cargo Coordinator Regulatory Compliance Resume Examples & Samples
- Must be able to read, write, fluently speak and understand the English language
- Computer experience in Excel, Word and PowerPoint desired
- Excellent written and verbal communication skills to interact effectively with necessary personnel
- Cognitive skills to interpret Local, State and Federal levels
21
Research Regulatory QA Coordinator Resume Examples & Samples
- Coordinates the implementation and maintenance of the Research Regulatory and Quality Assurance (QA) Program for the Institute in collaboration with Institute and central research administration management
- Oversees all Institute Q/A auditing, monitoring and training
- Assists with the establishment of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with those of the sponsoring organization, external regulatory agencies and central research administration offices
- Serves as a regulatory liaison with local, state and federal external agencies, communicating directly with agency personnel as necessary
- Coordinates the implementation and maintenance of the research education program, tracking participation and certification
- Coordinates all regulatory and quality audits and inspections, identifying and resolving compliance issues and concerns, developing and implementing quality improvement plans, defining standard scope of audit to mitigate future risk and reporting on research compliance activities
- Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics that drive improvement
- Maintains records, files and data for research regulatory and quality assurance efforts
- Minimum of three years research experience with a focus on research quality assurance and compliance
- Additional years of related experience may offset the degree requirements
- Research experience coordinating regulated research projects preferred
22
Regulatory & Document Control Coordinator Resume Examples & Samples
- Product, facility and state registrations and the filings associated with them, and
- Document preparation, control and maintenance, and
- Skills and responsibilities associated with the position of QA Coordinator
23
Lead Coordinator Regulatory Affairs Resume Examples & Samples
- Extracts and enters technical regulatory information into ERP computer system, ensuring data integrity and compliance with domestic and international device regulations
- Maintains accurate, up-to-date records and regulatory databases
- Responsible UDI submissions into FDA database
- Provides administrative support by ensuring accurate data entry and maintains data integrity within the enterprise system (SAP) to the entire corporation
- Work closely with all areas of RA Management to ensure accurate data and information is entered into SAP
- Manages the preparation and maintenance of U.S. FDA establishment registrations & product listings required for commercial distribution of medical devices and tissue products
- Manages the preparation and maintenance of state licenses required for commercial distribution of medical devices and tissue products
- Coordinates & manages requests for license & other regulatory information for external customers as needed
- Develop and build knowledge and skills around New Product Data Entry, Material Change requests and Discontinuations
- Business Process Development & Documentation. Analyze cross-functional information dependencies and systems impacts. Assist with development of business process and system solutions. Provide input and document processes. Develop working knowledge of SAP business processes
- Maintains close working relationship with Master Data Coordinator (MDC), or appropriate business partner, in order to insure data is complete and accurate prior to data entry
- Information Integration. Partner with applicable departments/units to ensure cross-functional integration of information and processes. Review functional specifications to ensure that business requirements are met
- Project Participation. Participate and engage in project meetings. Assist other team members with issue prioritization. Completes all assignments and project deliverables in a timely manner
- Data Management: Develop the ability and knowledge of creating and changing SAP master data in the areas of Material Master, BOM’s, Routes, QM Plans and other required areas. High volume of data entry required
- Excellent attention to detail and strong organizational skills
- Must demonstrate ability to work independently and exercise judgment with limited supervision
24
FAA / FCC Regulatory Compliance Coordinator Resume Examples & Samples
- Process routine regulatory review requests for collocation projects, tower modification projects, new construction and tower marking and lighting changes
- Escalate advanced regulatory review requests to senior team members
- Complete high volume data entry in company databases and governmental agency web-based databases
- Screen customer applications for regulatory holds; track all reviews in company database
- Process regulatory information requests from internal and external sources
- Correspond with processing counterparts in governmental agencies
- Correspond with project teams to convey compliance requirements and compliance review status
- Dispatch Field Operations personnel for on-site regulatory compliance verification work
- Review AM disturbance studies and Method of Moments reports
- Provide administrative support for internal regulatory audit projects
- Monitor team email inbox and respond to or distribute requests to appropriate team members
- Ability to work with functional groups and different level of employees to effectively and professionally achieve results
- Strong track record of building and maintaining solid relationships with internal and external customers and vendors
- Strong computer skills, including Microsoft Office suite
- Associate’s or Bachelor’s degree in Regulatory Compliance, Planning, or similar field strongly preferred
- Wireless telecommunication industry experience preferred
- Knowledge of FAA/FCC regulatory filing practices preferred
- Airspace & TERPS software program knowledge preferred
25
Regulatory Submission Coordinator Resume Examples & Samples
- Computer literacy in basic functions (Word, Excel)
- Good planning and organizational skills; detail oriented
- Flexibility, ability to switch back and forth between multiple projects/tasks
26
Registered Nurse Regulatory Compliance Coordinator Resume Examples & Samples
- Travel within Eastern Colorado Health Care System
- Two to three years of quality experience
- Possession of Basic Life Support Certification (BLS)
- Demonstrates leadership in delivering and improving holistic care through collaborative strategies with others
- Experience in administrative functions such as program management, standard operating procedures and policies; project management, and regulatory compliance
27
Coordinator, Regulatory Compliance Resume Examples & Samples
- Regulatory compliance of spirits exports
- Prepare, submit, and maintain record of TTB pre-export application (5100.11)
- Coordinate with customer service department and shipping facility to ensure timely completion & approval of all required elements of application
- Actively work across the organization to ensure all contributors are working in compliance with federal regulations
- Identify opportunities to train contributors. Develop & deliver training
- Administration of the matter management system and internal shared drive in their use as the department’s document management system
- Monitor status of applications pending with TTB and stakeholders using matter management reporting
- Evaluate controls are in place to successfully track all pending items and develop processes to improve efficiency of system, where necessary
- Provide status updates of pending applications to team on a monthly basis and as requested
- Coordinate with Manager, Regulatory Affairs, when necessary, to escalate matters that exceed a specified timeframe
- Distribute copies of all approved applications to stakeholders upon receipt
- Act as the database power user and owner of expectations guide document
- Provide training, when necessary, to new and established users. Serve as primary Point of Contact for questions & issues related to the system
- Monitor personnel changes within the organization and ensure Power of Attorney privileges are updated
- Perform periodic self-managed audits to confirm data integrity of system
- Assist with and participate in internal audits and licensing projects
- Complete desk audit work for assigned audits throughout the year
- Participate in on-site audit testing
- Maintain the export audit program and prepare all desk work for wine export audits
- As directed, prepare written requests to be submitted for TTB approval for Manager review & signature
- Assist with oversight of semi-monthly and monthly TTB filings for all Constellation facilities
- Serve as gatekeeper of company-wide internal compliance guide and distribute quarterly updates as directed
- Special projects, as needed
- Bachelor’s degree or a combination of education and equivalent work experience required
- Previous work experience with database administration required
- Experience with regulatory aspects of the alcohol beverage industry including Federal and State Alcohol Beverage Control laws preferred
- Strong constituent focus, attention to detail, analytical skills and computer skills (Microsoft Office) are essential
- Strong organizational & communication skills
- Valid driver’s license, a dependable vehicle & periodic local travel required
28
Coordinator Regulatory Integrity Resume Examples & Samples
- Manage all day~to~day activities associated with the organizational operation for government audits, e.g. Medicare Recovery Audit Contractor program (RAC), Medicare Comprehensive Error Rate Testing program (CERT), Office of the Inspector General (OIG) federal and state offices, Medicaid RAC, Supplemental Medical Review Contractor (SMRC), and all other current and future regulatory audits
- Manage the daily workload of the PFS Regulatory Integrity Analysts and Regulatory Integrity Data Liaisons. Maintain knowledge of Medicare guidelines and policies
- Manage, facilitate, analyze and coordinate the timely dissemination, and response to all regulatory functions, e.g. requests and appeals
- Recommend key improvement initiatives related to audit implementation, processes, financial reporting, education and the ongoing overall effectiveness of regulatory integrity function
- Promote interdepartmental collaboration between the Regulatory Integrity department and other departments at the Shared Revenue Cycle Organization (SRCO) as well as all Advocate Health Care facilities including Home Health Services (HHS), Advocate Medical Group (AMG), and Dreyer Medical
- Provide performance input and feedback to manager for PFS Regulatory Integrity Analysts
29
Project Coordinator Regulatory Affairs Resume Examples & Samples
- Text management including preparation, proof reading and release for print in accordance with current regulatory Directives, Regulations and guidelines of SmPC, PIL and labeling
- Setup implementation plans and provide labelling department with updated texts. Ensure that changes in printed packaging material are implemented in due time in the Nordics in relation to the FMD timelines
- Ensure close cooperation with FMD Project Manager, Labelling, Supply Chain and QA in implementation of FMD
- Proof reading and release of packaging material
- Regulatory handling of Change Controls / Non-conformities and other relevant databases
- Preparation and implementation of regulatory working instructions and SOPs
- Participate in the ongoing development of the department
- Negotiate with regulatory authorities in relation to FMD requirements
- Project management experience within the regulatory area
- Master degree in Pharmacy or Life science
- Pharmaconomist with regulatory background
- Nordic languages (preferred mother’s tongue)
- Preferred 2-5 years of regulatory experience
30
Lead Coordinator, Regulatory Submissions Ops Resume Examples & Samples
- Demonstrates specialized knowledge of preparation, formatting, copy, proof, and assembly of regulatory submissions and controlled documentation
- Assists publishers with tasks, such as pre-publishing (formatting, bookmarking, hyperlinking); self review and peer QC
- Applies knowledge/skills to a range of activities
- Completes work assignments with minimal supervision/guidance
- Creates navigation aids (i.e. bookmarks and hyperlinks) according to specified requirements
- Adds metadata to regulatory submissions per requirements
- Produces/publishes regulatory submissions in acceptable, compliant output according to specified guidelines and requirements
- Intermediate knowledge of MS Word and MS Excel
- Intermediate knowledge of Adobe Acrobat
- Working knowledge of spelling, grammar and punctuation
- Minimum of three years in office environment
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Product Compliance Coordinator Regulatory Compliance Resume Examples & Samples
- Lubes product knowledge essential. Product SDS, label, and product composition experience
- Must be able to speak, read and write local languages as appropriate – French and English essential
- Must have strong product, compliance or lubes business knowledge
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Coordinator, Regulatory Compliance Resume Examples & Samples
- Industry Licensing Compliance
- Supports TriNet’s attorneys and specialists in PEO licensing and annual report requirements with federal and state agencies
- Familiar with, or willing to learn and support, federal, state and local filing processes for professional employer organizations (PEO)
- Interfaces with management and executive team members to help coordinate periodic filing requirements
- Monitors federal, state and local laws and PEO regulations with regard to compliance reporting changes and processes and implement across company as needed
- Maintain and track regulatory reporting calendar
- Collect and organize files and update corporate files and records
- Manage one-off projects and licensing expansions
- Create documentation and procedures to scale and improve compliance efficiency
- Triage work on inquiries directed to TriNet’s legal department related to regulatory and PEO compliance
- Provide professional/technical guidance to various TriNet departments on matters related to the company’s licensure requirements and pending regulatory matters
- Regularly interfaces with government agencies and regulators to ensure continued licensing compliance
- Serves as company coordinator to manage ongoing data necessary to maintain independent ESAC accreditation
- Coordinates, prepares and files other related filings, including MEWA filings
- General Corporate Compliance and Maintenance
- Interfaces with TriNet attorneys, paralegals and corporate agents on a wide variety of customary corporate compliance issues, including state qualifications, business licensing and other unique state-by-state requirements
- Supports recordkeeping and annual compliance for our many subsidiaries, including maintaining business license and state qualification records
- Assist attorneys and paralegals with the formation and dissolution of subsidiaries in various state and international jurisdictions
- 3-5+ years of corporate compliance legal experience, preferably in regulated industries
- Permitting and licensing experience is a plus
- Past experience in a law firm or corporate legal department as a legal assistant or similar role a plus
- Gets stuff done
- An ability and desire to work in a fast-paced and dynamic work environment that requires flexibility and multitasking
- Willingness to embrace frequent change in all forms
- Attention to detail; strong writing skills
- A positive attitude with an ability to work proactively and prioritize
- The ability to work well independently as well as part of a team
- Strong business partnering skills
- Good sense of humor
- Ability to communication remotely with team members across the country
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Coordinator, Quality / Regulatory Audit Resume Examples & Samples
- Responsible for answering inbound calls from customers and making outbound calls to customers and responding to customer service tickets regarding order errors and other Compliance issues
- Duties will also include accurately and efficiently verifying and reviewing orders and processing buybacks
- Keying orders, performing cycle counts and processing order returns and new customer welcome kits
- Acts as a back-up to the Transportation Coordinator and supports purchasing when needed
- Other responsibilities to include but not limited to assuring compliance within the distribution center
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Coordinator, Regulatory Law Resume Examples & Samples
- Receive, review, enter into Case Track Rite Aid Suspicious Activity Reports, retrieve store information and money transfer transaction data from the Western Union CMR and, if appropriate, file with FinCEN
- Review Western Union transactional data (CMR) to identify suspicious activity not reported via SAR
- Complete various office duties such as answer the telephone, fax, copy, sort, and file
- Operate office machines, such as photocopiers and scanners, facsimile machines, voice mail systems and personal computers
- Interact with internal and external contacts with regard to various regulatory issues
- One (1) year of experience in working with microsoft required
- Or equivalent education in lieu of experience
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CMC Regulatory Sciences Coordinator Resume Examples & Samples
- Regulatory intelligence
- Maintains electronic system for cataloguing and tracking regulatory agency information requests, responses, and commitments for all CMC-RS submissions
- Prepares reports and metrics from the electronic system for cataloguing and tracking regulatory agency information requests and commitments
- Program tracking
- Tracks the due dates for Specialist deliverables to help identify resource constraints before they result in slipping timelines
- Coordinates the initiation of regulatory submission document reviews (e.g., cross-functional reviews and copyediting/data verification reviews with the CMC RS Document Quality group
- Provides submission coordination support
- Initiates SharePoint workflows
- Updates batch analysis tables as new lots are dispositioned
- Formats submission sections (e.g., stability and batch analysis tables)
- With guidance/oversight of specialists, organizes the product SharePoint folders into a consistent scheme with improved navigability
- Tracks ex-US commercial filings completed by partners
- Creates/maintains content trackers for regulatory submissions for assigned programs
- Keeps management and others informed on progress of CMC-RS deliverables for assigned programs
- Department support
- Prepares agendas and minutes for group and department meetings. Prepares group and department newsletters
- Requires Associates degree plus 2 years of relevant experience; BS/BA in a scientific discipline preferred
- Requires strong organizational skills – will need to do many things at once and keep tabs on multiple projects; strong verbal and written communication skills, and strong reporting skills, including fluency in MS Word and Excel
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Regulatory Affairs International Coordinator Resume Examples & Samples
- Monitor and respond to questions posed by international regulatory associates via the Regulatory Requests Mailbox
- Maintain various tracking logs to track project approvals and product releases
- Arrange visits by international visiting associates
- Maintain international regulatory contact list
- Assist with general administrative responsibilities, such as setting up department meetings, filing, preparing regulatory submissions, tracking submission details and metrics, department communication, etc
- Complete Certificate to Foreign Governments (CFG), Certificates of Free Sale (CFS), obtaining Apostille, and maintain the Medical Device Listings/Establishment Registrations
- Effectively track and monitor invoices to ensure payments are processed in a timely fashion via the ARIBA system
- Associates Degree or higher preferred
- Minimum 2 – 4 years experience as a global regulatory affairs department assistant
- Proficiency of Microsoft Office 2007 (Word, Excel, and Outlook)
- Able to create reports and manipulate data
- Flexibility - able to adapt to compliance cycle activities and demanding timelines
- Must be well organized, able to multi-task and work with limited supervision
- Proactive, taking the initiative when needed
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Admin / Coordinator, Regulatory Affairs Resume Examples & Samples
- Create, organize, manage, and make paper and/or electronic copies of files and documentation including global registrations, technical files, design dossiers, and certificates
- Manage Global RA Regulatory documentation
- Obtain documents required for regulatory registrations such as Certificates of Free Sale, and Certificates to Foreign Government
- Manage legalization of documents to support registrations
- Facilitate the preparation of regulatory presentations for meetings and trainings
- Support the Global Regulatory Affairs Department with travel planning
- 1-2 years’ experience in document control in a regulated environment
- Demonstrated ability to use databases and prepare documents and presentations
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Coordinator Regulatory White Oils & Food Resume Examples & Samples
- Ensure chemicals used in formulating our products are registered for import into strategic geographical regions
- Manage preparation activities for compliance with the European REACH Chemical reporting program and TSCA Chemical Inventory. Monitor Global Chemical Control Regulatory Changes, research future registries, regulations and restrictions that have potential to affect lubricants products. Coordinate with sales / distributors where appropriate
- Align the regulatory compliance business process with other PCLI processes (e.g. ISO Standards, Operational Excellence Management System, Regulatory Compliance)
- Supporting the development, drafting and submission and supporting information for amendments, extensions and new applications to the EPA, PMRA, NSF, CFIA, FSMA etc
- Supporting the Research and Development and Product Categories in the interpretation of regulations, and regulatory advances and on the appropriate strategic approach for approval application, schedules and compliance
- Maintains current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.) and shares knowledge with the internal stakeholders
- Continues to improve internal regulatory processes and work with the stakeholders to improve consultation practices, processes and relationships
- Ensure regulatory compliance for all current and new products globally
- Execute strategies and tactics related to regulatory processes
- Interaction with Product Safety and Marketing teams
- 1-3 years’ experience in the White Oil/Food regulatory field
- Worked in a GMP environment
- Knowledgeable and experienced in registrations with Health Canada (CFIA) and US FDA
- Knowledge and Understanding of ISO 9001, ISO 14001, ISO 22000
- Product safety experience in a chemical or related industry
- Knowledge of safety, health, and environmental legislation in Ontario, Canada, USA, Europe, China/Asia, Latin America
- Knowledge and experience in global chemical control laws, hazard communication requirements including US TSCA and REACH
- Work well with government agencies and many levels within the organization
- Good problem solving skills and strong communication skills
- Change facilitator; proactive continuous improvement mindset
- Self-motivated individual contributor; comfortable working in a team environment
- Results oriented
- Demonstrated customer focus
- Continuing to improve internal regulatory processes and working with the stakeholders to improve consultation practices, processes and relationships
- Stops and/or reports any unsafe work or conditions
- Follows safety & environmental policies and procedures
- Supports safety & environmental goals and initiatives
- Participates in safety & environmental meetings, training, emergency drills and hazard recognition programs
- Reports all accidents, injuries and near misses, and participates in associated investigations
- Participates in industrial hygiene, medical surveillance and behavior based safety programs
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Regulatory Report Coordinator Resume Examples & Samples
- Minimum 1 year work experience with a focus on project management
- Strong document management and organizational skills
- Proven leadership skills, initiative and ownership of deliverables
- Ability to work effectively in matrix organizational structure
- Self-starter, fast learner with ability to innovate and perform in a fast-paced team environment
- Must have excellent written and verbal communication and interpersonal skills
- Proficient with computer systems (MS Office necessary; Advanced Excel and Word skills preferred) and document management systems (i.e. FirstDoc, Documentum, SharePoint)
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Regulatory Research Coordinator Resume Examples & Samples
- CCRA (Certified Clinical Research Associate)
- CCRP (Certified Clinical Research Professional)
- RAC (Regulatory Affairs Certification)
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Technical Coordinator, Regulatory Reporting Resume Examples & Samples
- To have a thorough understanding of the technical aspects/exceptions of the Clients in the Reporting process
- Perform quality assurance checks on the reports prepared by junior members in the team before delivering to Home Location
- Work closely with counterparts in home locations to resolve queries
- Create, maintain and update procedures/processes
- Ensure compliance with all controls and procedures outlined in the procedures manual and general company policies
- Review and sign off on the tasks completed by the team members and also on day-to-day deadlines during production cycles
- Work closely with the Team Leader and Section Manager for on-boarding new transitions and staff
- Ensure mock funds are prepared and procedure documents are maintained prior to on-boarding of new clients. Point out issues/exceptions observed and resolved these accordingly with Home Location’s assistance
- Ensure all scheduled work is completed by agreed deadlines, checklists are signed and files are complete
- Identify and implement process improvements to reduce risk and develop efficiency of function
- Ensure that technology is available and fully utilized in the most efficient manner
- Ensure full and proper reporting and escalation of any operational issues
- Escalate and communicate any service delivery issues (for example, late reporting) as identified
- On-going review of daily controls and communications of suggested procedural changes
- To assist with training and coaching of new team members
- Knowledge of financial / capital markets (e.g., Good understanding of financial instruments, operation of capital markets, lifecycle of trade, valuations etc.)
- Excellent desktop, IT and systems skills. Knowledge of Microsoft Office (especially MS Excel and Word) is essential
- Knowledge of US GAAP, UK SORP & IFRS through studies and/or work experience (preferred)
- Knowledge of related systems: Bloomberg, Reuters (preferred)
- Excellent interpersonal skills, as this role requires interaction at all levels of the organisation and externally, fluent English necessary
- 4 - 6 years experience in preparation of financial statements, regulatory reports, client and board reports of a Hedge Fund, Mutual Fund or financial institution
- Bachelor’s degree in Accounting or Finance
- Certified Public Accountant (CPA) is required
- Background in regulatory / statutory reporting will be preferred
- Minimum of 18 months experience in the process area
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Technical Coordinator, Regulatory Reporting Resume Examples & Samples
- To have a thorough understanding of the technical aspects/exceptions of the Clients in Reporting process
- Ensure mock funds are prepared and procedure documents are maintained prior to on-boarding of new clients
- Point out issues/exceptions observed and resolved these accordingly with Home Location’s assistance
43
Global Regulatory Transaction Review Program Coordinator Resume Examples & Samples
- Performing project management and status reporting
- Reviewing, analyzing and reporting on the Teams performance metrics
- Preparing executive reporting and dashboards
- Coordinating deliverables and requests with key business stakeholders
- Facilitating meetings with key business stakeholders
- Maintaining policies, standards, procedures, process and training documentation
- Coordinating team deliverables and activities
- Supporting the Team’s technology
- Onboarding new associates
- Maintaining inventory of process improvements and execution status
- Bachelor's Degree (Accounting or Finance Strongly Preferred)
- Four+ years of experience in audit, risk or compliance (or other testing functions)
- Strong networking and relationship management
- Detail orientated
- Strong process improvement mindset
- Proficient in Microsoft Office (Excel, Word and PowerPoint)
- Knowledge of FR Y-14 Q/M data elements and requirements
- Proficient in Microsoft Access, Visio and Project
- Proficient with SharePoint
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CAO Operations Regulatory Exam Coordinator Resume Examples & Samples
- 10+ years experience with in Compliance, Risk, Controls or other related experience
- Knowledge of regulators’ exam processes and/or background in regulatory matters a plus
- Excellent organizational skill and the ability to manage, prioritize, work under pressure and meet tight deadlines
- Ability to build effective working relationships and interact comfortably with regulators and with a wide spectrum of colleagues
- Strong written and verbal communication skills; ability to self-edit and respond effectively to regulators, compliance partners and to JPMC management
- Strong interpersonal and influencing skills, with the ability to establish credibility and strong partnership with senior business/compliance partners
- Attention to detail and commitment to doing quality work in a comprehensive manner
- Keen interest in policy, governance, and regulations
- Strong technical skills – PowerPoint, Word, Excel
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BMT Quality & Regulatory Program Coordinator Resume Examples & Samples
- Bachelor’s Degree required, Masters preferred
- Demonstrated relevant experience (5 years minimum)
- Quality, Accreditation, Patient Safety, or Regulatory Compliance experience is strongly preferred
- BMT experience is strongly preferred
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Study Start Up Regulatory Submissions Coordinator Resume Examples & Samples
- Collects, reviews, organizes, and assembles regulatory start-up submissions
- Interacts with ethics committees and regulatory agencies
- Negotiates and then prepares Informed Consent Forms (ICF) for the study sites to ensure the site meets local requirements
- Prepares, reviews, and files clinical trial applications to domestic and international regulatory agencies; and,
- Tracks submissions and ensures timely filing of documents
- A Bachelor's degree in a relevant field
- 1 - 3 years of job experience in a clinical trial environment
- Knowledge of local regulations regarding clinical studies and the conduct of such studies
- Strong oral and written communication skills; and
- Excellent computer skills, including a working knowledge of Microsoft Office applications
