Associate Director, Regulatory CMC
PepGen
AI assistant
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.
This is a hybrid role, in office Tues-Thurs
Key Responsibilities
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.
This is a hybrid role, in office Tues-Thurs
Key Responsibilities
- Develop and execute global regulatory CMC strategies for assigned development activities,