Senior Global Regulatory Compliance Leader

Repligen-Corporation

Waltham (MA)

On-site

USD 130,000 - 190,000

Full time

9 days ago

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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

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

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