Senior Manager, Regulatory Compliance

Repligen Corporation•Waltham, MA

16h

About The Position

The Senior Manager, Regulatory Compliance leads Repligen’s global product regulatory compliance programs to support continued market access and compliance with applicable international regulations and standards. The role provides leadership for regulatory professionals and partners with Quality, Engineering, Product Management, Operations, Supply Chain, Legal, Commercial, and other functions. It establishes operational objectives, develops compliance strategies, and drives initiatives covering product and environmental compliance, market access, product stewardship, and customer regulatory requirements. The role translates corporate regulatory strategy into operational processes and builds organizational capability and compliance excellence. It manages multiple compliance programs and may oversee direct reports and external resources. The position oversees compliance with global product regulations and standards, supports regulatory requirements throughout the product lifecycle, integrates requirements into product development and change management, and leads risk assessments and mitigation planning. It also directs customer compliance support and supplier data and documentation processes, supports audits and regulatory assessments, and drives compliance tools, metrics, records management, and audit readiness. The role manages departmental budgets and external service providers and 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.
At least 8 years of experience in Regulatory Affairs, Product Compliance, Quality Systems, Environmental Compliance, or a related field.
At least 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 for 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 and global market access requirements.
Lead cross-functional compliance initiatives across business units and product platforms.
Monitor emerging global regulations, assess business impact, and develop implementation strategies and compliance roadmaps.
Drive continuous improvement of compliance processes, systems, and metrics.
Oversee programs addressing regulations and standards including EU RoHS, REACH and SCIP, TSCA, PFAS requirements, CE Marking, UKCA, WEEE, PPWR, Conflict Minerals, Responsible Minerals Reporting, and country-specific product requirements.
Provide strategic guidance on compliance throughout the product lifecycle and ensure requirements are integrated into product development, design control, and change management.
Lead regulatory risk assessments and support mitigation planning for compliance gaps.
Oversee customer compliance support, including responses to regulatory inquiries and requests for 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 Regulatory Compliance team members; establish performance objectives and development plans.
Build accountability and a high-performance culture focused on collaboration, service excellence, and continuous improvement.
Support workforce planning, resource allocation, and succession planning; mentor regulatory professionals and strengthen organizational regulatory competency.
Partner with cross-functional teams to implement regulatory requirements and influence 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 regulatory 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.