Global Regulatory Compliance Leader — Equity & Bonus Eligible

Regulatory Jobs; Waltham (MA); Sur place; USD 130 000 - 190 000; Plein temps

Avantages offerts par ce poste

Bonus program

Health/dental/vision insurance

Retirement benefits

Résumé du poste

Repligen is seeking a Senior Manager, Regulatory Compliance to lead global regulatory programs across products and development activities. You will partner with Quality, Engineering, Product Management, Operations, and Legal to drive compliant business outcomes and governance across regions.

The role requires strategic regulatory leadership, program management, and the ability to translate regulatory strategy into actionable operational processes while mentoring a team of professionals.

Qualifications

• Bachelor's degree in a technical discipline and 8+ years in Regulatory Affairs or related field.
• Minimum 4 years of people management experience.

Responsabilités

• Lead global regulatory compliance programs for products and development activities.
• Develop and execute strategies aligned with market access requirements.
• Coordinate cross-functional initiatives across Quality, Engineering, Product Management and Operations.
• Monitor evolving global regulations and implement compliant roadmaps.
• Oversee audits, regulatory inquiries, and documentation workflows.
• Mentor and develop the Regulatory Compliance team and manage budgets.

Connaissances

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Regulatory risk assessment

Formation

Bachelor's degree in Engineering/Regulatory Affairs/Quality/Science

Master's degree (preferred)

Description du poste

Repligen is seeking a Senior Manager, Regulatory Compliance to lead global regulatory programs across products and development activities. You will partner with Quality, Engineering, Product Management, Operations, and Legal to drive compliant business outcomes and governance across regions.

The role requires strategic regulatory leadership, program management, and the ability to translate regulatory strategy into actionable operational processes while mentoring a team of professionals.