Senior Manager, Regulatory Compliance
- Compensation
- Not disclosed
- Location
- Waltham, MA
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 4+ years
- Category
- Not specified
- Posted
Skills
Must have
- Bachelor's degree in Engineering, Regulatory Affairs, Quality, Chemistry, Biology, Environmental Science, or related technical discipline.
- Minimum 8 years of experience in Regulatory Affairs, Product Compliance, Quality Systems, Environmental Compliance, or related field.
- Minimum 4 years of people management experience.
- Demonstrated experience leading cross-functional regulatory or compliance programs.
- Strong knowledge of global product compliance regulations and standards.
- Experience interacting with customers, suppliers, test laboratories, and regulatory agencies.
Nice to have
- Master's degree in Engineering, Regulatory Affairs, Quality, Business, or related discipline.
- RAC, ASQ CQE, or equivalent professional certification.
- Experience in biotechnology, life sciences, medical devices, laboratory equipment, or bioprocessing industries.
- Experience with compliance management systems and supplier data management platforms.
Full description
The Senior Manager, Regulatory Compliance is responsible for leading and managing Repligen's global product regulatory compliance programs to ensure continued market access and compliance with applicable international regulations and standards. This role provides leadership for a team of regulatory professionals and serves as a key partner to Quality, Engineering, Product Management, Operations, Supply Chain, Legal, and Commercial teams.
The Senior Manager establishes operational objectives, develops compliance strategies, and drives execution of global regulatory initiatives related to product compliance, environmental compliance, market access, product stewardship, and customer regulatory requirements. This position plays a critical role in translating corporate regulatory strategy into effective operational processes while building organizational capability and compliance excellence across the business. This role manages multiple regulatory compliance programs and may oversee direct reports and external resources.
This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.
Essential Duties and ResponsibilitiesRegulatory Compliance Leadership
- Lead and manage global regulatory compliance programs supporting commercial products and new product development activities.
- Establish operational objectives, priorities, policies, and procedures for the Regulatory Compliance function.
- Develop and execute regulatory compliance strategies aligned with company growth objectives and global market access requirements.
- Lead cross-functional compliance initiatives impacting multiple business units and product platforms.
- Monitor emerging global regulations and assess business impact, developing implementation strategies and compliance roadmaps.
- Drive continuous improvement of regulatory compliance processes, systems, and metrics.
Product Compliance
- Oversee programs supporting compliance with global product regulations and standards, including but not limited to: EU RoHS, REACH and SCIP, TSCA, PFAS regulations and reporting requirements, CE Marking, UKCA, WEEE, Packaging and Packaging Waste Regulation (PPWR), Conflict Minerals and Responsible Minerals Reporting, Country-specific product compliance requirements.
- Provide strategic guidance on compliance requirements throughout the product lifecycle.
- Ensure regulatory compliance requirements are integrated into product development, design control, and change management processes.
- Lead regulatory risk assessments and support mitigation planning for identified compliance gaps.
- Oversee customer compliance support processes, including responses to regulatory inquiries and requests for compliance documentation.