Regulatory Affairs Project Manager Resume Samples
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Regulatory Affairs Project Manager Resume Samples
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AV
A Vandervort
Antone
Vandervort
58547 Keeling Radial
Houston
TX
+1 (555) 627 1621
58547 Keeling Radial
Houston
TX
Phone
p
+1 (555) 627 1621
Experience
Experience
Philadelphia, PA
Regulatory Affairs Project Manager
Philadelphia, PA
Reichel-Purdy
Philadelphia, PA
Regulatory Affairs Project Manager
- Identifies, evaluates, plans, performs and implements process improvement initiatives focused on existing regulatory processes
- Monitor submission preparation progress and work with subject matter experts to ensure that submission content is provided in a timely fashion
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Provides Regulatory leadership to development teams
- Develop global regulatory strategies for UDI implementation and maintenance to ensure regulatory effective dates are met and act as a direct liaison with regulatory authorities. This includes maintaining the product label database
- 3) Prepare and submit PMA, IDE, 510(k) and international product registrations and licensing applications (original submission and subsequent product enhancements.)
- Review, analyze and approve technical data generated by Engineering, Manufacturing, Marketing, Quality Assurance or other related departments for filing purposes
Phoenix, AZ
Regulatory Affairs Project Manager
Phoenix, AZ
Hand, Robel and Welch
Phoenix, AZ
Regulatory Affairs Project Manager
- Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
- Create and maintain Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported
- Maintain an active awareness of EU legislation and assess its impact on AbbVie business and R&D programmes jointly with RI. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
- Lead project teams while providing regulatory direction to development project teams; develops and communicates regulatory strategy for new products
- Manage and execute preapproval compliance activities
- Manages the development of dossiers for registration of products in countries outside the U.S
present
Detroit, MI
Biocides Regulatory Affairs Project Manager
Detroit, MI
Leffler, Hand and Strosin
present
Detroit, MI
Biocides Regulatory Affairs Project Manager
present
- Working with project managers to ensure client and regulatory deadlines are met
- Strong commitment to safety, including following established Health and Safety protocols
- Good working knowledge of relevant software systems (IUCLID and R4PB)
- Strong commitment to delivering high quality work that exceeds clients’ expectations
- Coordination of projects, including setting up of biocide project, client liaison and on-time delivery of work to clients and meeting regulatory deadlines
- Actively involved with the preparation of dossiers and project co-ordination in support of Project Managers
- Work closely with clients, representing JSC in client meetings and act as a focal point for selected key clients
Education
Education
Bachelor’s Degree in Science
Bachelor’s Degree in Science
Central Michigan University
Bachelor’s Degree in Science
Skills
Skills
- Excellent organizational skills and extreme attention to detail
- Strong analytical skills are highly desired
- Strong technical writing skills are highly desired
- Working knowledge of design and licensing basis for nuclear plants is highly desired
- Working knowledge of nuclear power plant design and systems is highly desired
- Ability to quickly learn, interpret and master complex protocol information
- Ability to work effectively in a team environment and build strong working relationships
- Pay strong attention to detail
- Excellent written and verbal communication skills
- Analytical ability & practical approach
15 Regulatory Affairs Project Manager resume templates
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1
Biocides Regulatory Affairs Project Manager Resume Examples & Samples
- Provide high quality regulatory support on biocides projects, including project co-ordination, contact with clients, regulatory bodies and to other JSC staff to meet regulatory and business needs
- Coordination of projects, including setting up of biocide project, client liaison and on-time delivery of work to clients and meeting regulatory deadlines
- Understand client’s desired outcomes and work collaboratively to ensure deliverables meet quality standards
- Contribute to the commercial growth of the business through actively participating in the wider business development activities such as client visits, conferences, and expert groups relevant to expert area, as appropriate
- Actively involved with the preparation of dossiers and project co-ordination in support of Project Managers
- Develop and maintain expertise in biocides and gain awareness of other regulatory areas as required
- Work closely with clients, representing JSC in client meetings and act as a focal point for selected key clients
- Working with project managers to ensure client and regulatory deadlines are met
- Provide client and internal support on BPR and Guidance as required
- Maintain and develop expertise in relevant regulatory areas according to the requirements of the business
- Assist in the personal development of other members of the JSC team, as appropriate
- Undertake other scientific and administrative tasks on occasion, where this benefits the business as a whole
- Educated to degree level within Biology, Chemistry or other related disciplines
- Knowledge of the EU regulatory process for biocidal products
- Practical experience of the preparation and support of biocide dossiers within the EU
- Good working knowledge of relevant software systems (IUCLID and R4PB)
- Practical understanding on the use and application of biocidal products
- Experienced in project management
- Strong commitment to delivering high quality work that exceeds clients’ expectations
- Strong commitment to safety, including following established Health and Safety protocols
- Effective written/verbal communication and organization/analytical skills
- Excellent inter-personal skill with the ability to lead project team and passion to help others develop
2
Regulatory Affairs Project Manager Resume Examples & Samples
- Create and maintain Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported
- Coordinate with DevSci Project Managers to ensure program timelines are integrated and accurately reflect cross functional dependencies
- Create and maintain program dashboards for teams and management utilizing defined processes and tools
- Document project deliverables and track progress
- Monitor submission preparation progress and work with subject matter experts to ensure that submission content is provided in a timely fashion
- Track post marketing commitments and annual reporting requirements and ensure all deadlines are met
- Establish product registration tracking events and schedule regulatory submissions
- Support Regulatory Strategy meetings, including scheduling meetings (as needed), facilitating discussions, documenting actions and conducting all necessary follow-up
- Support Regulatory Sub-team operations, including facilitation of Sub-team and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required), under the supervision of the Project Manager
- Support short and long-term planning activities for project teams
3
Regulatory Affairs Project Manager Resume Examples & Samples
- Develop global regulatory strategies for UDI implementation and maintenance to ensure regulatory effective dates are met and act as a direct liaison with regulatory authorities. This includes maintaining the product label database
- Manage and maintain CE Technical Files and product schedules and make appropriate submittals to the EU Representative and Notified Body
- Prepare US submissions, including, but not limited to FDA Drug and Device Listings and establishment registration, 510(k) submissions, 513(g) requests
- Prepare reports/license applications to state health boards, as required, e.g., controlled substances, suspicious order monitoring, pedigree compliance
- Interpret existing or new regulatory requirements as they relate to company products/operations and procedures, clinical studies, testing, records, etc. to ensure ongoing compliance
- Provide regulatory guidance and support to project teams including regulatory filing strategies, testing and standards requirements
- Review, analyze and approve technical data generated by Engineering, Manufacturing, Marketing, Quality Assurance or other related departments for filing purposes
- Review, provide feedback and approve design and manufacturing changes, nonconforming materials reports, test protocols and reports to ensure regulatory compliance with FDA, Health Canada, Medical Device Directive (MDD), ISO 13485 and applicable standards and determine filing or notification requirements
- Provide guidance, review and approve promotional and advertising materials, product claims, training materials, Instructions for Use, technique guides, labels and other related labeling to ensure compliance with regulations
- Manage post market surveillance activities, i.e., adverse event reporting and field corrective actions
- Work closely with Quality Assurance and participate in internal and external audits as well as communicating with regulatory officials, as necessary
- Participate in special projects and performs other duties as required
- Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including World Wide Business Standards
- Perform the position’s duties in a professional manner, supporting Ortho Organizers’ and HF Acquisition Co.’s Quality Policy. Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA’s Quality System Regulations (21 CFR 820) and cGMP for drugs (21 CFR 211) and ISO Standards (ISO 13485) is required
- Demonstrated ability to lead and manage projects
- Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
- Excellent organizational skills and extreme attention to detail
- Excellent written and verbal communication skills to include interacting with both internal personnel and external organizations (regulatory authorities, customers, distributors, etc.)
- Ability to prioritize, multi-task and adapt to change
- Ability to work within budget constraints and to work with minimal to no guidance to perform job function
- Ability to work effectively in a team environment and build strong working relationships
- Ability to read, analyze and interpret common scientific and technical journals, legal documents, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents
- Ability to respond in a timely manner to inquiries and complaints from regulatory agencies
- High degree of initiative and self-motivation with a strong sense of accountability
- Word processing skills, including Microsoft Word, Excel, and PowerPoint
4
Regulatory Affairs Project Manager Resume Examples & Samples
- Participate on product development teams to insure US and EU regulatory requirements are incorporated as part of the development process
- Author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)’s, IDE’s, PMA’s, Technical Files, and Design Dossiers
- Review and approve labels, labeling and marketing/sales collateral materials for pre and post - market applications
- Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers
- Address and advise teams on appropriate pathways to market
- Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues
- Establish and maintain regulatory information systems both electronically and hard copy
- Interpret existing and/or new regulatory requirements as they relate to company products and procedures
- Review and approve change requests with regard to US and EU regulatory requirements
- Prepare and update US product listings and EU registrations
- Communicate any regulatory body correspondence on submissions to the appropriate team(s) and RA management
- Develop, implement and maintain regulatory SOP’s
- Conduct quality and regulatory training
- 510(k), IDE, PMA (original/revision/supplements) preparation experience
- Preparation of EU Technical Files and Design Dossiers
- Minimum 4-5 years experience in FDA and EU regulated medical device industry
- Working knowledge of FDA and EU Medical Device Regulations
- Direct interaction with FDA reviewers/inspectors
- Direct interaction with Notified Bodies and Competent Authorities
- Team based work environment experience preferred
- Strong interpersonal, written, oral, communication and organizational skills
- Working knowledge of personal computer systems and desktop office applications
- Sound understanding of scientific principles
- Quality assurance experience a plus
5
Regulatory Affairs Project Manager Resume Examples & Samples
- Gain marketing authorisations for new pharmaceutical products in the UK and Malta where appropriate
- Maintain marketing authorisations as required
- Gain regulatory authority approval for new clinical trials and amendments to such trials undertaken by AbbVie Ltd in the UK and Malta as appropriate
- Liaise with European Regulatory Affairs and Corporate groups on regulatory issues
- Liaise with external regulatory authorities as required
- Draft of packaging texts, SmPCs, PILs and Prescribing Information
- Review of material in accordance with The Prescription Medicines Code of Practice Authority (PMCPA)/ABPI Code
- Liaise and attend meetings with other company functions to provide regulatory advice for new/existing products
- Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements
- Lead/manage regulatory or affiliate projects and interact with other departments as necessary
- Mentor regulatory staff as required
- Act as deputy to the Regulatory Affairs Manager and indirectly to Director, Regulatory Affairs & QA as required
- Life Sciences Degree or equivalent experience
- Varied regulatory experience including clinical trials and promotional material review
- The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
- Effective project management experience
- Experience in people management would be desirable
6
Regulatory Affairs Project Manager Resume Examples & Samples
- Project manager for regulatory projects of various sizes
- Identifies, evaluates, plans, performs and implements process improvement initiatives focused on existing regulatory processes
- May deliver presentations including measurement, analysis, improvement and control
- Surveys and analyzes best practices for regulatory techniques and processes
- Communicates team progress and performs benefit analyses
- 2+ years working in a regulatory environment in healthcare, pharmaceutical, Medicare or related field with Federal and/or State regulatory requirements
- 2+ years managing projects of various sizes
- Advanced knowledge of MS Office products (Word, PowerPoint and Excel- formulas, pivots, etc.)
- Proven ability to multi-task and prioritize work
- Ability to research and interpret federal, state and local regulatory regulations
- Ability to work with cross functional teams to ensure regulatory requirements are incorporated into the development process
- Experience providing presentations to various sized groups
7
Regulatory Affairs Project Manager Resume Examples & Samples
- A Bachelor’s degree (BS or BA) in an applicable scientific or health science field such as biochemistry, chemistry, pharmacy or pharmacology is required
- At least four (4) years or more of experience with Perrigo or another company in the Pharmaceutical, medical device or other medical products/health care industry with progressive experience managing projects of complexity, is required
- Hands on experience in Regulatory Affairs, or a combination of an advanced degree in Regulatory Affairs or closely allied field and relevant practical training in the field, is also required
- Strong financial acumen, including capabilities in project governance and risk assessment, budget management, and the ability to organize and balance resources across project goals
- Must possess excellent analytical skills and the ability to apply policies and general regulations to specific products or projects with minimal direction
- Well-developed communication skills are essential, including excellent written, verbal, and interpersonal skills
- Excellent documentation skills and the ability to coordinate multiple projects and priorities in order to meet required due dates is required
- Travel of approximately 10% (primarily to the Perrigo Minnesota site) may be required
8
Regulatory Affairs Project Manager Resume Examples & Samples
- Implement regulatory strategies & deliverables typically for late development and marketed products in the assigned Therapeutic Area for the WE Area (including Israel, Turkey and Switzerland). In alignment with the overarching global regulatory strategy and region specific requirements
- May receive delegation to represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met. Duly reports on activities in these teams and alerts his/her management when necessary
- Propose a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates. (Area Regulatory Product Team ARPT)
- Primary RA interface with Commercial. Represent RA on the Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product)
- Primary interface to and from the RA personnel in the affiliates
- Primary interface with local health authorities (via RA personnel in the affiliates
- Receives delegation for direct liaison with EMA for products within the Therapeutic area
- Provide leadership and support to RA personnel in the affiliates (through ongoing communication. Assess scientific data provided by specialist units for registration (and re-r) purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs)
- Maintain an active awareness of EU legislation and assess its impact on AbbVie business and R&D programmes jointly with RI. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established
- Implements the EU processes to achieve local HA input into R&D Programmes and regulatory approval
- Provide Area input on local implications through participation in Teams as needed (e.g., submission teams, labelling working group: development of labelling negotiations)
- Ensure regulatory compliance within WE for the assigned compounds/products. Implement remediation plan to address identified gaps, if any
- A Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required
9
Regulatory Affairs Project Manager Resume Examples & Samples
- Restricted substances (e.g. REACH)
- International Experience
- Regulatory Operations
- Submission/registration types and requirements
- GxPs (GCPs, GLPs, GMPs)
- International treaties and regional, national, local and territorial trade requirements, agreements and considerations
- Communicate with diverse audiences and personnel
- Write and edit technical documents
- Work with cross-functional teams
- Work with people from various disciplines and cultures
- Negotiate internally and externally with regulatory agencies
- Pay strong attention to detail
- Juggle multiple and competing priorities
- Think analytically with good problem solving skills
- Define regulatory strategy
- Perform risk assessment or analysis
- Lead functional groups in the development of relevant data to complete a regulatory submission
10
Regulatory Affairs Project Manager Resume Examples & Samples
- Develop new regulatory policies; processes and SOPs and train key personnel on them
- Evaluate regulatory risks of division policies; processes; procedures
- Provide regulatory input to product lifecycle planning
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
- Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
- Assist in regulatory due diligence for potential and new acquisitions
- Utilize technical regulatory skills to propose strategies on complex issues
- Determine submission and approval requirements
- Identify emerging issues
- Monitor trade association positions for impact on company products
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Recruit; develop and mentor regulatory professionals
- Assess the acceptability of quality; preclinical and clinical documentation for submission filing
- Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
- Compile; prepare; review and submit regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Monitor applications under regulatory review
- Communicate application progress to internal stakeholders
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Provide strategic input and technical guidance on regulatory requirements to development teams
- Manage and execute preapproval compliance activities
- Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
- Ensure compliance with product post marketing approval requirements
- Review and approve advertising and promotional items to ensure regulatory compliance
- Ensure external communications meet regulations
- Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
- Actively contribute to the development and functioning of the crisis/issue management program
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
- Report adverse events to regulatory agencies and internal stakeholders
- Provide regulatory input for product recalls and recall communications
- 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 4-5 years experience in a regulated industry (e.g., medical products, nutritionals)
- M.S. in Regulatory Affairs/Regulatory Science is preferred
- 5+ years of experience in IVD assay development and/or regulatory
- 2-5 years of experience with IVD submissions/registrations (US and/or International)
11
Regulatory Affairs Project Manager Resume Examples & Samples
- Coordinate and track all regulatory projects
- Acts as a liaison with department and outside department personnel to fulfill project/departmental goals
- Reviews deliverables prepared by team before passing to other cross-functional teams
- Conduct regular status meetings with all cross-functional teams and foreign subsidiary offices to ensure projects are being completed in a timely manner
- Requests, compiles, and files appropriate regulatory documentation for Product Information Files
- Acts as liaison between consultants and the regulatory team to ensure all invoices are paid in a timely manner
- Minimizes our exposure and risk on regulatory projects
- 3-5 years of Project Management or related experience
- In-depth knowledge of and prior experience using MS Project or other project management software
- In-depth knowledge of and prior experience using Excel
- Experience coordinating and facilitating meetings
- Experience working in a shared services or cross-functional model
- Must be able to function under pressure in fast paced corporate environment, highly organized, meet demanding deadlines, think creatively, ability to negotiate, resolve timeline failure issues and mitigate consequences, and lead teams effectively
- Ability to work across teams, groups and functions and to build strong relationships
- Employee is frequently required to sit for extended periods of time and may be required to talk and listen to employees and/customers
- Employee is occasionally required to stand for long periods of time; walk; use hands to finger, handle, or feel; and reach with hands and arms
- Employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
12
Regulatory Affairs Project Manager Resume Examples & Samples
- Bachelor’s Degree in any field
- Must have Clinical Research Certification (CCRC, CCRA, RAC, etc.) or have adequate experience to obtain certification within 1 year of start date
- The position requires extensive, diverse and progressively responsible experience at the management level, including direct responsibility for clinical research, regulatory affairs, and personnel management
- Substitution: Clinical research regulatory experience may substitute for the degree only on a year for year basis. For example, 4 years of clinical research regulatory experience may substitute for the bachelor's degree, but NOT for the Clinical Research Certification
- 3 years of clinical research regulatory experience
- Experience with/understanding of contract language
- Experience with regulatory submissions to federal agencies (e.g., FDA)
- Experience with University of Colorado Denver regulatory policies and procedures
- Experience with filing Investigational New Drug Applications (INDs) and requesting IND exemption determinations
- Ability to quickly learn, interpret and master complex protocol information
- Possesses advanced knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials
- Demonstrated commitment and leadership ability to advance diversity and inclusion
- Knowledge of medical terminology and computers
13
Regulatory Affairs Project Manager Resume Examples & Samples
- Manages FDA regulatory submission process; oversees the authorship and publication of electronic submissions
- Manages the development of dossiers for registration of products in countries outside the U.S
- Lead project teams while providing regulatory direction to development project teams; develops and communicates regulatory strategy for new products
- Manages the development and review processes for proposed labeling for compliance with applicable U.S. and international regulations
- Supervises the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status of the product
- Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization
- Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products
- Responsibility for oversight and prioritization of departmental tasks and projects
- Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors, peers, and direct reports
- Ability to lead a team, influence others and. Strong organizational skills and development project experience qualify the occupant to lead teams and handle increasing levels of responsibilities
- 6-8 years of experience in Regulatory Affairs
- Experience in orthopaedic or medical device strongly preferred
- Regulatory Affairs Certification (US or EU) preferred
- Combination of education and experience may be considered
14
Regulatory Affairs Project Manager Resume Examples & Samples
- 5 years or more project management experience required
- Medical device industry experience required
- Quality or regulatory experience preferred
15
Regulatory Affairs Project Manager Resume Examples & Samples
- Minimum 5 years of Regulatory Affairs &Operations and best practices experience in several regulatory areas (including dossier preparations and submissions, variation management (including EU procedures), CMC)
- IDMP knowledge
- RIMS Experience (Research Information Management Systems)
- Experience in working within the pharmaceutical and/or software industry
- Change Management Controls
- Regulatory Renewals
16
Regulatory Affairs Project Manager Resume Examples & Samples
- Medical Master Degree or above, preferable in Endocrinology
- Min 3+ years experience in RA area in pharmaceutical industry or related industry like medical devices or healthcare industry
- Experience in pharmaceutical marketing, R&D or medical affairs functions is preferred
17
Regulatory Affairs Project Manager Resume Examples & Samples
- Develops sound global regulatory strategies for new and modified medical devices
- Prepares robust regulatory applications to achieve departmental and organizational objectives
- Creates, reviews and approves engineering changes
- Provides leadership and guidance (including training) to other members of the RA staff
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations
- Provides Regulatory leadership to development teams
- BA or BS degree (degree in a technical discipline highly preferred)
- Minimum 6 years regulatory experience; 8 years preferred
- Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
- Ability to work in a highly matrixed and geographically diverse business environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to travel approximately 5%, including internationally
- Ability to maintain regular and predictable attendance
- Ability to work independently with no oversight
- Ability to identify and solve problems in a strategic manner
- Ability to manage complex projects
- Ability to be proactive and not reactive, to anticipate changing business and regulatory environments
18
Regulatory Affairs Project Manager Resume Examples & Samples
- Develop regulatory submissions such as 510(k), PMA, IDE and Annual/Periodic Reports to US FDA, and Design Dossier, Technical Files and Notice of Change to EU notified body and other regulatory agencies
- Maintain international technical files/dossiers/registrations as required
- Participates in new product development teams, develops regulatory strategies, and provides regulatory support consistent with regulatory strategies
- Reviews and approves document change orders and engineering documentation (EDC)
- Interfaces with Regulatory Agencies as required
- Prepares for facility registration, device listing, periodic reports etc. per U.S. FDA requirements and the requirements of foreign markets
- Assembles Common Technical Document (CTD) and electronic filings for USFDA and other international regulatory agencies
- Interprets, executes and recommends modification to internal guidelines, work instructions, and procedures related to regulatory affairs
- Monitors industry and regulatory trends to develop strategies and provide appropriate guidance
- Tracks the status of regulatory submissions during submission development and review/approval progress and communicates to management
- Bachelor’s degree in Life Sciences or Engineering
- 5+ years medical device regulatory affairs experience with USFDA and international submissions
- Knowledge of US and international submission requirements and US and International regulations
- Demonstrated ability to work with minimal supervision on multiple concurrent tasks/activities and meet corporate strategies and goals
19
Regulatory Affairs Project Manager Resume Examples & Samples
- 1) Serve as a mentor for Regulatory Affairs Coordinators, Associates, and Assistants
- 2) Develop global regulatory strategies for new and modified products
- 3) Prepare and submit PMA, IDE, 510(k) and international product registrations and licensing applications (original submission and subsequent product enhancements.)
- 4) Maintains a professional demeanor and technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings
- 5)Interpret new or existing regulatory requirements as they relate to AVD products and procedures
20
Regulatory Affairs Project Manager Resume Examples & Samples
- Proactively develops action plans and implements all activities, to achieve the timely and efficient registration of high quality submissions (market authorizations, clinical trials and post-market variations) for all assigned BI products within timelines specified by Corporate Office or local Management. This includes
- B.Sc. or higher degree in life sciences (e.g. pharmacology or pharmacy) with significant experience in drug regulatory affairs in a pharmaceutical industry
- Thorough knowledge and understanding of federal regulations/guidelines concerning development, manufacturing and sale of pharmaceutical products
- Excellent Project Management skills, i.e. superior organizational, written and oral communication skills, the ability to work independently as well as to collaborate effectively with team members locally and internationally to meet strict deadlines
- Good working knowledge of business office software applications including word processing (e.g. Microsoft Word, Word Perfect), presentations (e.g. PowerPoint) and databases (e.g. Access or regulatory databases for other environments)
- Candidates with less experience may be considered at the Regulatory Affairs Associate level *
21
Regulatory Affairs Project Manager Resume Examples & Samples
- The Joseph M. Farley Nuclear Plant near Dothan, Ala
- The Edwin I. Hatch Nuclear Plant near Baxley, Ga
- The Alvin W. Vogtle Electric Generating Plant near Waynesboro, Ga
- Performs research to develop or support formal licensing positions and strategies for potential conditions adverse to quality, issues of concern, and emerging generic issues
- Counsels management and executives on regulatory planning and strategies
- Advises the plant sites to address issues that have regulatory implications; performs regulatory analyses and provides insights for decision-makers
- Provides expertise in plant licensing basis, as well as generic and plant-specific licensing issues
- Regularly interfaces with NEI, NRC, and other utilities to develop positions and strategies for regulatory issues; being able to influence and provide industry leadership is key in this role
- Is expected to serve as a mentor to other licensing engineers in the department
- Availability for after-hours plant support is required
- SNC emergency response organization support may be required; therefore, the selected candidate must live within one hour of the SNC Emergency Operations Facility for emergency response availability
- Bachelor of Science degree in engineering from an accredited college or university is required
- Ten years (10) of power plant operations or other related industrial experience is desired
- Five year (5) or more years of experience in the nuclear industry is required
- Previous experience managing or influencing a team of employees is highly desired
- Prior NRC experience is highly desired (resident or regional inspector, NRR experience, etc.)
- Working knowledge of the Reactor Oversight Process, NRC procedures, and NRC regulations
- Advanced degree, professional engineering license, or other specialty certifications is a plus
- Previous SRO license or certification is highly desired
- Plant specific knowledge of Farley, Hatch, or Vogtle plants is desired but not required
- Typically works independently to uncover and resolve complex regulatory and licensing issues
- Critical decision-making ability to understand the regulatory consequences and impacts of actions
- Must exhibit an exceptional degree of regulatory expertise, creativity, and resourcefulness
- Working knowledge of nuclear power plant design and systems is highly desired
- Working knowledge of design and licensing basis for nuclear plants is highly desired
- Ability to represent SNC at NRC and industry meetings is desired
- This position must possess extensive knowledge that enables them to lead and participate in professional committees
- Strong technical writing skills are highly desired
- Strong analytical skills are highly desired
- Ability to communicate well, to make presentations to senior SNC management, and to build trusting relationships with the NRC is required
22
Regulatory Affairs Project Manager Resume Examples & Samples
- Compile and submit drug master file for active pharmaceutical ingredients and other substances (i.e. U.S., Canada, Europe, Asia, Mexico, and South America)
- Correspond with regulatory agencies and customers regarding submissions
- Compile and submit responses to questions regulatory agencies have regarding submissions
- Maintain schedule and complete annual reports for all regulatory submissions
- Maintain records of all regulatory submissions and associated Letters of Authorization/ Letters of Access
- Maintain records of all correspondence with regulatory agencies and customers
- Compile and submit Site Master Files to support GMP operations
- Compile technical data packages for active pharmaceutical and other substances for use by customers in the preparation of their own submissions