Senior Manager, Regulatory Compliance

Repligen-Corporation; Waltham (MA); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Bonus program

Health/dental/vision

Paid time off

Retirement benefits

Equity potential

Job summary

Repligen is seeking a Senior Manager, Regulatory Compliance to lead global regulatory programs and ensure market access for commercial and new products. You will collaborate with Quality, Engineering, Product Management, Operations, Supply Chain, Legal and Commercial teams to translate regulatory strategies into robust processes.

You will manage a team of regulatory professionals, drive KPI-based performance, and oversee regulatory audits and supplier documentation efforts, with a focus on

Qualifications

• Bachelor's degree in a technical field with 8+ years regulatory experience.
• Demonstrated leadership in cross-functional regulatory programs.
• Strong knowledge of global product compliance regulations and standards.

Responsibilities

• Lead and manage global regulatory compliance programs for commercial products.
• Establish objectives, policies, and procedures for Regulatory Compliance.
• Develop and execute strategies aligned with global market access.
• Oversee regulatory risk assessments and mitigation planning.
• Mentor and develop Regulatory Compliance team members.

Skills

Regulatory affairs

Product compliance

Quality systems

Environmental compliance

Leadership

Cross-functional collaboration

Regulatory audits

Stakeholder management

Education

Bachelor's degree in a technical field

Master's degree (preferred)

Job 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 LeadershipLead 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 ComplianceOversee 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.Direct supplier compliance data collection and assessment activities.Establish frameworks and processes for managing supplier declarations, material disclosures, and regulatory documentation.Support key customer audits and regulatory assessments as required.Lead, coach, and develop Regulatory Compliance team members.Establish performance objectives and development plans aligned with departmental and organizational goals.Build accountability and foster a high-performance culture focused on collaboration, service excellence, and continuous improvement.Support workforce planning, resource allocation, and succession planning activities.Mentor regulatory professionals and enhance organizational regulatory competency.Partner with Quality, Engineering, R&D, Product Management, Operations, Procurement, and Commercial teams to ensure regulatory requirements are effectively implemented.Influence decision-making across functions to support business objectives while maintaining compliance.Present compliance status, risks, and strategic recommendations to senior management.Lead cross-functional efforts to resolve complex compliance issues and regulatory challenges.Drive implementation and optimization of regulatory compliance tools, databases, and digital solutions.Establish and monitor regulatory compliance metrics and key performance indicators.Ensure appropriate documentation, records management, and audit readiness.Support internal audits, external audits, customer audits, and regulatory inspections.Manage departmental budgets and external service providers associated with compliance programs.Leadership ResponsibilitiesProvides direct leadership and supervision to regulatory compliance professionals.Translates strategic objectives into operational plans and measurable outcomes.Leads multiple regulatory programs and initiatives across global business functions.Makes operational decisions influencing departmental performance and long-term compliance objectives.Builds strong relationships with internal stakeholders, external consultants, customers, suppliers, and regulatory authorities.Education and ExperienceRequiredBachelor'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.PreferredMaster'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.What Repligen OffersOur mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $130,000-$190,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.