Global Regulatory Compliance Leader

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

Job summary

Repligen Corporation is seeking a Senior Manager, Regulatory Compliance to lead global product regulatory compliance programs and build organizational capability across Quality, Engineering, Product Management, Operations, and Commercial teams.

The role drives regulatory strategies, integrates compliance into product development, and leads a team of regulatory professionals to ensure market access and ongoing compliance with international standards.

Qualifications

• Bachelor’s degree in Engineering, Regulatory Affairs, Quality, Chemistry, Biology, Environmental Science, or related 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.

Responsibilities

• Lead global regulatory compliance programs supporting commercial products and new product development activities.
• Establish objectives, policies, and procedures for Regulatory Compliance functions.
• Develop and execute strategies aligned with growth and global market access requirements.
• Lead cross-functional compliance initiatives across multiple business units.
• Monitor emerging global regulations and implement roadmaps for compliance.
• Drive continuous improvement of regulatory compliance processes and systems.

Skills

Leadership

Regulatory affairs

Cross-functional

People management

Education

Bachelor’s degree in Engineering or related

Master’s degree preferred

RAC certification preferred

Tools

Regulatory databases

Supplier data management platforms

Job description

Repligen Corporation is seeking a Senior Manager, Regulatory Compliance to lead global product regulatory compliance programs and build organizational capability across Quality, Engineering, Product Management, Operations, and Commercial teams.

The role drives regulatory strategies, integrates compliance into product development, and leads a team of regulatory professionals to ensure market access and ongoing compliance with international standards.