Global Regulatory Compliance Leader

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

Benefits offered by this job

Health/dental/vision

Paid time off

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corp in Waltham, MA is seeking a Senior Manager, Regulatory Compliance to lead global product regulatory programs and ensure market access across regions. You will guide a team of regulatory professionals and partner with QA, engineering, product management, operations, procurement, and legal to translate regulatory strategy into scalable processes.

The role emphasizes building capability, managing budgets and external resources, and driving continuous improvement, with opportunities to

Qualifications

• 8+ years in Regulatory Affairs or related fields.
• 4+ years of people management experience.
• Strong knowledge of global product compliance regulations and standards.
• Experience leading cross-functional regulatory programs.

Responsibilities

• Lead and manage global regulatory compliance programs for products.
• Develop and execute compliance strategies aligned with growth and market access.
• Oversee global product compliance activities including supplier and customer documentation.
• Lead, coach, and develop the regulatory compliance team and partners.

Skills

Regulatory leadership

Cross-functional leadership

People management

Strategic planning

Education

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

Master's degree preferred in Engineering/Regulatory Affairs/Quality/Business

Job description

Repligen Corp in Waltham, MA is seeking a Senior Manager, Regulatory Compliance to lead global product regulatory programs and ensure market access across regions. You will guide a team of regulatory professionals and partner with QA, engineering, product management, operations, procurement, and legal to translate regulatory strategy into scalable processes.

The role emphasizes building capability, managing budgets and external resources, and driving continuous improvement, with opportunities to