Senior Regulatory CMC Lead — Global Submissions & Equity

PepGen, Inc.; Boston (MA); Presencial; USD 148.000 - 220.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Discretionary annual bonus

Equity

Health insurance (medical, dental, and

Vision

401(k) plan

Paid time off and holidays

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CMC leadership

Global submissions

Regulatory strategy

FDA/EMA knowledge

Cross-functional collaboration

Educación

Bachelor's degree in chemistry

Advanced degree preferred (MS/PhD/PharmD)

Descripción del empleo

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