Global Regulatory Compliance Lead - Product Stewardship

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

Benefits offered by this job

Paid time off

Health/dental/vision insurance

Retirement benefits

Flexible spending accounts

Job summary

Repligen is seeking a Senior Manager, Regulatory Compliance to lead global regulatory programs for existing and new products. You will partner with Quality, Engineering, Product Management, Operations, and Commercial teams to translate regulatory strategy into robust operational processes.

The role emphasizes leadership, compliance excellence, and cross‑functional influence. The position requires a strong track record in global product regulations, audits, and supplier interactions, with 8+

Qualifications

• Bachelor'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.

Responsibilities

• Lead 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.

Skills

Regulatory leadership

Global compliance

Cross-functional collaboration

Regulatory strategy

Regulatory audits

Compliance management systems

Supplier data platforms

Education

Bachelor's degree in engineering/regulatory/quality/chemistry/biology/environmental science

Tools

Compliance management systems

Supplier data platforms

Job description

Repligen is seeking a Senior Manager, Regulatory Compliance to lead global regulatory programs for existing and new products. You will partner with Quality, Engineering, Product Management, Operations, and Commercial teams to translate regulatory strategy into robust operational processes.

The role emphasizes leadership, compliance excellence, and cross‑functional influence. The position requires a strong track record in global product regulations, audits, and supplier interactions, with 8+