Senior Manager, Regulatory Compliance Job Description
Senior Manager, Regulatory Compliance Duties & Responsibilities
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Sample responsibilities for this position include:
Senior Manager, Regulatory Compliance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Manager, Regulatory Compliance
List any licenses or certifications required by the position: CRCM, CPA, CIA, CFSA, CAMS, GCF, PTCRB, ATP, PMP, ISACA
Education for Senior Manager, Regulatory Compliance
Typically a job would require a certain level of education.
Employers hiring for the senior manager, regulatory compliance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Business, Finance, Accounting, Law, Engineering, MBA, Management, Economics, Legal, Science
Skills for Senior Manager, Regulatory Compliance
Desired skills for senior manager, regulatory compliance include:
Desired experience for senior manager, regulatory compliance includes:
Senior Manager, Regulatory Compliance Examples
Senior Manager, Regulatory Compliance Job Description
- Identifying and supporting business development initiatives
- Review existing and changing laws, to translate them (with minimal legal support) into forms usable by the business
- Lead on design, delivery and implementation of business focussed compliance training
- Ensure appropriate working paper evidence of findings is maintained
- Manage performance of on-site audit work and review working papers for sufficient scope and accuracy when audit lead
- Maintain IAS standards, in the planning, execution and reporting
- Responsible for the creation, issuance and updating of product documentation
- Utilize analytical skills to review and assess profit and funding mix forecasts, funding, contingency, recovery and resolution plans and remediation activities related to contingent liquidity
- Focus on capturing market risk exposures and work closely with local risk managers to develop risk measures and limits for all non-trading market risk portfolios across all regions and entities
- Analyze risk positions to identify if any material risks are currently unreported or unhedged
- IFIC Mutual Funds Course or Canadian Securities Course, and Partners, Directors, Officers course, Chief Compliance Officer’s course are required
- Full understanding of all significant laws, regulations, and regulatory compliance requirements applicable to portfolio management and/or financial planning firms
- Reports to the Senior relationship manager
- 5-10 Years Leadership role in Audit, Compliance, Risk Management related to Outsourcing or Supplier Risk Management
- Leadership experience in Assurance, Testing, Reporting
- Excellent facilitation, written and oral communication and presentation skills, ability to communicate effectively with Senior and Executive Management and Operating/Oversight Committees
Senior Manager, Regulatory Compliance Job Description
- Oversight for RESL business on annual CDIC FID testing
- Ensure that operations within area of responsibility are in compliance with applicable internal and external requirements by completing periodic control testing and reviews
- Manage the quarterly, annual and ad hoc regulatory reporting process ensuring compliance with the SEC, FINRA, Federal Reserve and State requirements
- Assist and support users and presenters in report interpretation and utilization
- Collaborate and coordinate FDA interactions and submission activities with Marketed Product and Development Regulatory Leads in Global and Development Regulatory Groups
- Review and prepare regulatory documents for eCTD submission to FDA in compliance with requirements including Meeting Requests, Briefing Documents, CMC and Labeling supplements, General Correspondence, Annual Reports and Periodic Safety Reports, and other submissions
- Technical assessment of submission content against commitments, regulations, and guidance documents
- Review of protocols, and additional regulatory documentation as required
- Maintain appropriate documentation for FDA contacts and submissions according to SOPs
- Update and maintain Regulatory department tracking databases for planning, scheduling, submissions, action dates, and overall project coordination and management
- This role needs to lead without authority and be able to collaborate with multi stakeholders and deliver results
- BS (or higher) degree in engineering, biotechnology, biomedical, material science or related field
- Over 10 years’ experience (3-5 years of experience in manager position) preferably in medical device, bio-pharm or pharmaceutical industry environment
- Experience of quality system requirements to worldwide markets
- Attention to detail in setting, conducting, and documenting
- Ability to communicate efficiently with the experts in other scientific and technical fields, and a willingness to learn new skills
Senior Manager, Regulatory Compliance Job Description
- Interacts with Executive Leadership in business, Compliance and Legal on matters impacting Regulatory Operations
- Provides compliance advice with respect to the portfolio of regulatory reports supported by Regulatory Operations
- Supports business and IT efforts to ensure data quality and consistency standards are met
- Under direction of Chief Compliance Officer for Operations, Finance & Technology, supports special projects or initiatives related to strategic operation of the Compliance team and Compliance Framework
- Agency liaison for NDA/BLA supplements, maintenance activities, and OPDP submissions, as required
- Management of NERC CIP-002 BES Cyber Asset Identification Process across Eversource
- Management of NERC CIP-014 Physical Security Program
- Bulk Electric System Facility Identification Process
- ISO-NE Thermal Ratings Process
- Asset Retirement Obligations for Transmission and Distribution
- Medical Device audit certification(s)
- ONESTEP & other internal quality management systems (ETMS)
- Bachelor Degree in Life Science or related discipline, higher degree preferable (Pharm.D., MSc, PhD, MBA)
- Minimum of five years of experience within the biotech/pharma industry
- Understanding of the US laws/regulations related to Clinical Development
- Professional experience in a global / multi-national company environment (Pharma/Biotech/CRO)
Senior Manager, Regulatory Compliance Job Description
- Providing timely advice to the business in support of eNett’s growth (as per position overview above)
- Providing analysis as required on the impact of changing or new AML/CTF and sanctions regulatory obligations on the business
- Supporting first line operations in evaluation of any unusual/suspicious behaviour
- Monitor changing regulation and log proposed and impending changes, and log them as appropriate into information-sharing and collaboration tools (currently sharepoint)
- Build and maintain the Group's Obligations registers – including facilitating the regulatory change implementation process
- Support the Deputy CRO – Regulatory Risk and Compliance and team
- Support and advise management concerning regulatory implementation projects, as appropriate
- Develop and manage productive internal and external control relationships with Operational Risk, Compliance, GAML, Privacy, Legal, Consumer Legislation, Audit, and Strategic Sourcing
- Work with RESL partners to mitigate exposure to regulatory and reputational risks by ensuring a strong control environment
- Represent RESL at monthly Risk Officer meetings convened by TDCT Operational Risk and Canadian Privacy
- Previous experience with the processes and functions of Regulatory Affairs
- Professional experience in process improvement initiatives as it relates to the Regulatory Affairs function and wider scope of the drug development lifecycle
- Position may require up to 20% travel, domestic and/or international
- Prefer 7-10 years of experience in food/beverage, flavor or related industry
- Prefer 5 years minimum in Regulatory Compliance for senior specialist role
- Minimum 2 years proven/demonstrated management skills
Senior Manager, Regulatory Compliance Job Description
- Work collaboratively with business leadership teams to proactively meet strategic objectives for internal investigations, local employment compliance, employment contract management, federal regulation compliance
- Identify compliance issues and consult appropriate business partner(s) to address difficult issues that may require additional follow-up or broad investigation
- Provide leadership and expertise in interpreting and evaluating risk associated with audit findings and provides direction and support to Business and Quality groups in the development of corrective action plans that systemically address issues
- Participating in periodic status meetings convened by Strategic Sourcing group relating to the material outsourced relationship with material 3rd party vendor relationships
- Review monthly FCAC complaints report and participate in any investigation or remediation activity coordinated by FCAC Compliance
- Facilitating remediation/tracking of findings by Audit, Regulators and other Risk and Compliance oversight groups including Global AML
- Coordinate all activities related to BCMs, RCSAs, Audits, KRI reporting
- Management and compliance to AML segment policy, Risk Assessments and AML/ABAC Testing
- Oversight of various reporting for compliance and controls, including semi-annual SOX certification
- Annual review of Regulatory Policy/Compliance’s documented controls
- Is expected to operate with a high degree of autonomy once Conduct project plans are approved and reporting and governance requirements are established with the Head of RC Conduct Risk
- Is expected to collaborate with the Head of RC Conduct Risk to create education and communications plans, then operate with a high degree of autonomy to implement those plans once they are approved and reporting and governance requirements are established
- Is expected to advise the Head of RC, Conduct Risk on the work to advise and challenge RC Monitoring and Testing
- Will report to the Head of RC Conduct Risk, who reports, in turn to the Head of Regulatory Compliance (Canada) and the Global Head of Conduct Compliance
- Ability to maintain confidentiality, integrity, and transparency
- Knowledge and experience in change management and conflict resolution, an understanding of how decision making impacts others and strategic thinking