Senior Regulatory CMC Lead — Global Submissions (Hybrid)

PepGen, Inc.; Massachusetts; Hybrid; USD 148,000 - 220,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health insurance

Life insurance

Disability Insurance

Paid time off

Parental leave

401(k) plan

Cell phone reimbursement

Student loan repayment

529 contributions

Lifestyle spending account

Job summary

PepGen is seeking an experienced Associate Director of Regulatory Affairs CMC to lead global regulatory CMC activities, develop strategies, and guide cross-functional teams through clinical development and late-stage readiness.

Reporting to the Executive Director, this hybrid role requires strong technical expertise, regulatory judgment, and collaboration across CDMOs and CROs to ensure timely submissions and compliant CMC content.

Qualifications

• 8+ years in pharma/biotech with at least 5 years Regulatory CMC experience.
• Experience leading global regulatory CMC activities and submissions for clinical-stage products.
• Involvement in NDA/Module 3 strategy and CMC documentation.
• Strong understanding of drug substance/product development and control strategies.

Responsibilities

• Lead global regulatory CMC strategies for assigned development activities.
• Evaluate development plans, manufacturing processes, analytics, and control strategies for regulatory needs and risks.
• Independently plan and coordinate CMC content for INDs, CTAs, IMPDs, and regulatory amendments.
• Develop regulatory positions and respond to Health Authority questions to support briefing packages.
• Assess impact of manufacturing/analytical changes on regulatory requirements and region filing implications.
• Lead activities supporting technology transfer, process validation, and phase-appropriate controls.
• Contribute to late-stage planning including Module 3 data strategy and gap analysis.
• Coordinate with CROs, CMOs, and Regulatory Operations to ensure timely submissions.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Regulatory judgment

Project management

Education

BSc in Chemistry

Advanced degree (MS/PhD/PharmD)

Job description

PepGen is seeking an experienced Associate Director of Regulatory Affairs CMC to lead global regulatory CMC activities, develop strategies, and guide cross-functional teams through clinical development and late-stage readiness.

Reporting to the Executive Director, this hybrid role requires strong technical expertise, regulatory judgment, and collaboration across CDMOs and CROs to ensure timely submissions and compliant CMC content.