Associate Director, Regulatory Affairs CMC

PepGen; Boston (MA); On-site; USD 148,000 - 220,000; Full time

Benefits offered by this job

Discretionary annual bonus

Equity

Health insurance (medical, dental, and

Vision

401(k) plan

Paid time off and holidays

Job summary

PepGen is seeking an experienced Associate Director, Regulatory Affairs CMC to lead global regulatory CMC activities for our Enhanced Delivery Oligonucleotide (EDO) programs in Boston. This role reports to the Executive Director, Regulatory Affairs CMC and drives regulatory strategy, submissions, and health authority interactions throughout clinical development.

The ideal candidate has 8+ years in pharmaceutical/biotech with direct Regulatory CMC experience, strong technical knowledge of drug

Qualifications

• Bachelor's degree in chemistry or related scientific discipline.
• 8+ years in pharma/biotech with 5+ years Regulatory CMC.
• Experience leading global regulatory CMC activities and submissions.
• Involvement in NDA/IND/Module 3 content and regulatory responses.
• Experience with outsourced CDMOs/CROs and cross-functional teams.

Responsibilities

• Develop global regulatory CMC strategies for development activities and guide cross-functional teams.
• Assess drug substance/product development, manufacturing, analytical methods, and control strategies for regulatory needs.
• Lead planning, authoring, review, and coordination of CMC content for global submissions (INDs, CTAs, IMPDs, amendments).
• Develop regulatory positions and prepare CMC responses to Health Authority questions.
• Oversee changes affecting regulatory filings, comparability, and region-specific requirements.
• Support technology transfer, process validation, and phase-appropriate control strategies.
• Contribute to Module 3 strategy and regulatory readiness for late-stage programs.
• Coordinate with Regulatory Operations and regional reps to ensure timely, consistent CMC information.
• Monitor evolving global regulatory guidelines and translate into practical recommendations.

Skills

CMC leadership

Global submissions

Regulatory strategy

FDA/EMA knowledge

Cross-functional collaboration

Education

Bachelor's degree in chemistry

Advanced degree preferred (MS/PhD/PharmD)

Job description

PepGen is seeking an experienced Associate Director, Regulatory Affairs Chemistry, Manufacturing and Controls (CMC), to contribute to the development of our novel Enhanced Delivery Oligonucleotide (EDO) therapeutics for neuromuscular and neurological diseases.

Reporting to the Executive Director, Regulatory Affairs CMC, this individual will independently lead assigned global Regulatory CMC activities, develop and execute regulatory strategies, and provide scientific and regulatory guidance throughout clinical development and late-stage readiness. The role requires strong technical expertise, sound regulatory judgment, and the ability to work effectively across functions in a dynamic, clinical-stage biotechnology environment.

Key Responsibilities

• Develop and execute global regulatory CMC strategies for assigned development activities, providing proactive regulatory guidance to CMC, Analytical Development, Quality, and other cross-functional teams.
• Evaluate drug substance and drug product development plans, manufacturing processes, analytical methods, specifications, impurity control, stability, and control strategies to identify regulatory requirements, risks, and potential mitigation strategies.
• Independently lead the planning, authoring, review, and coordination of CMC content for global regulatory submissions, including INDs, CTAs, IMPDs, amendments, annual reports, and Health Authority briefing packages.
• Develop regulatory positions and lead preparation of CMC responses to Health Authority questions, contributing to meeting strategies, briefing materials, and regulatory interactions.
• Assess the regulatory impact of manufacturing, analytical, testing, and supply chain changes, including comparability requirements, regional filing implications, and implementation strategies.
• Lead assigned regulatory activities supporting technology transfer, process validation, and the development of phase-appropriate control strategies.
• Contribute to late-stage and registration-readiness planning, including Module 3 content strategy, CMC data requirements, and identification of development or documentation gaps.
• Coordinate with Regulatory Operations, regional regulatory representatives, CROs, and external manufacturing partners to ensure timely submissions and consistency of CMC information across regions.
• Monitor evolving global regulatory requirements, guidance, and precedents, translating relevant developments into practical recommendations for CMC development and regulatory strategy.
• Represent Regulatory CMC on assigned cross-functional teams, independently managing deliverables, communicating regulatory risks and recommendations, and supporting effective decision-making.

Required Qualifications

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, biology, or related scientific discipline.
• Minimum 8 years of relevant pharmaceutical or biotechnology industry experience, including at least 5 years of direct Regulatory CMC experience.
• Demonstrated experience independently leading global regulatory CMC activities and submissions for clinical-stage pharmaceutical or biotechnology products.
• Demonstrated Regulatory CMC experience in late-stage development and preparation of an NDA, including direct involvement in CMC strategy and Module 3 authoring or review.
• Strong technical understanding of drug substance and drug product development, manufacturing processes, analytical development, specifications, stability, and control strategies, with the ability to critically evaluate underlying scientific and technical data.
• Experience assessing manufacturing and analytical changes, comparability requirements, and associated regulatory implications.
• Experience working in an outsourced development and manufacturing model, including collaboration with CDMOs and CROs.
• Working knowledge of FDA, EMA, ICH, and other global regulatory CMC requirements, with experience preparing Health Authority briefing materials and regulatory responses.
• Strong regulatory judgment, communication, and cross-functional leadership skills, with demonstrated ability to independently manage competing priorities and develop scientifically justified recommendations.

Preferred Qualifications

• Advanced degree (MS, PhD, PharmD, or equivalent) in a relevant scientific discipline.
• Experience with oligonucleotides, peptides, conjugated therapeutics, or other complex or emerging modalities.
• Experience with sterile injectable drug products.
• Regulatory CMC experience in APAC regions.
• Experience working in a small or mid-sized biotechnology company with a lean Regulatory Affairs organization.

Compensation

The estimate full-time salary range for this role is between $148,000 to $220,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.

PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.