Senior Manager, Regulatory Compliance

RepliGen Corporation • Waltham, MA

2d • $130,000 - $190,000

About The Position

The Senior Manager, Regulatory Compliance leads and manages Repligen’s global product regulatory compliance programs to support continued market access and compliance with applicable international regulations and standards. The role leads a team of regulatory professionals and partners with Quality, Engineering, Product Management, Operations, Supply Chain, Legal, Commercial, R&D, and Procurement teams.

The position establishes operational objectives, develops compliance strategies, and drives global initiatives related to product compliance, environmental compliance, market access, product stewardship, and customer regulatory requirements. It translates corporate regulatory strategy into operational processes and builds organizational capability and compliance excellence. The role manages multiple regulatory programs and may oversee direct reports and external resources.

The Senior Manager models Repligen’s Leadership Behaviors: Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results.

Requirements

• Bachelor’s degree in Engineering, Regulatory Affairs, Quality, Chemistry, Biology, Environmental Science, or a related technical discipline.
• Minimum 8 years of experience in Regulatory Affairs, Product Compliance, Quality Systems, Environmental Compliance, or a 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 Haves

• Master’s degree in Engineering, Regulatory Affairs, Quality, Business, or a 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.

Responsibilities

• Lead and manage global regulatory compliance programs supporting commercial products and new product development.
• Establish operational objectives, priorities, policies, and procedures for the Regulatory Compliance function.
• Develop and execute compliance strategies aligned with company growth objectives and global market access requirements.
• Lead cross-functional compliance initiatives across business units and product platforms.
• Monitor emerging global regulations, assess business impacts, and develop implementation strategies and compliance roadmaps.
• Improve regulatory compliance processes, systems, and metrics.
• Oversee programs for global product regulations and standards, including EU RoHS, REACH and SCIP, TSCA, PFAS requirements, CE Marking, UKCA, WEEE, PPWR, conflict and responsible minerals reporting, and country-specific requirements.
• Provide strategic guidance on compliance throughout the product lifecycle and integrate requirements into product development, design control, and change management.
• Lead regulatory risk assessments and support mitigation planning for compliance gaps.
• Oversee responses to customer regulatory inquiries and requests for compliance documentation.
• Direct supplier compliance data collection and assessment, and establish processes for supplier declarations, material disclosures, and regulatory documentation.
• Support customer audits and regulatory assessments as required.
• Lead, coach, and develop team members; set performance objectives and development plans; and support workforce planning, resource allocation, and succession planning.
• Build team accountability and a high-performance culture focused on collaboration, service excellence, and continuous improvement.
• Partner with internal functions to implement regulatory requirements and influence cross-functional decisions while maintaining compliance.
• Present compliance status, risks, and strategic recommendations to senior management.
• Lead cross-functional resolution of complex compliance issues and regulatory challenges.
• Drive implementation and optimization of compliance tools, databases, and digital solutions.
• Establish and monitor compliance metrics and key performance indicators.
• Ensure appropriate documentation, records management, and audit readiness; support internal, external, and customer audits and regulatory inspections.
• Manage departmental budgets and external service providers associated with compliance programs.
• Translate strategic objectives into operational plans and measurable outcomes, make operational decisions affecting departmental performance, and build relationships with stakeholders, consultants, customers, suppliers, and regulatory authorities.

Benefits

• Paid time off
• Health insurance
• Dental insurance
• Vision insurance
• Retirement benefits
• Flexible spending accounts
• Eligible employees may participate in a variable cash program (bonus or commission). Eligible roles may receive equity as part of the compensation package.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior