PepGen
Senior Director, Regulatory CMC
PepGen is at an exciting time in our development. This role is for a motivated and team‑orientated individual who flourishes in an environment where they can help lead and shape our future.
As an integrated member of the PepGen Team you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the development and life‑cycle management of investigational products, including risk management and compliance requirements, authoring, compiling and/or reviewing CMC modules for regulatory submissions for investigational new drugs, clinical trial applications, and meeting briefing documents and responses to health authority queries.
In addition, working closely with our CMC and Quality organization, you will provide valuable regulatory support on technical and quality activities, such as manufacturing process development, specifications, in‑process controls, stability protocols, and change control management, and product and compliance quality initiatives.
About the Team As a member of this team, you will feel the excitement, passion, and pure joy that comes from being part of an innovative company with a focused mission.
Responsibilities
Command the attention and lead higher level managers and senior subject matter experts.
Demonstrate leadership, problem‑solving abilities, flexibility, and foster strong team relationships, with excellent written and oral communication skills.
Be independently motivated, possess effective analytical and problem‑solving skills, with the ability to navigate complex clinical regulatory challenges.
Maintain a detail‑oriented mindset and exceptional organizational skills, adapting to dynamic and evolving regulatory landscapes.
Requirements
Bachelor’s degree at a minimum, preferably a PhD in a Life Science area (or equivalent experience).
In-depth knowledge of regulatory guidelines and requirements for the development and manufacturing of pharmaceutical products, preferably with nucleic acid‑based therapies.
Hands‑on CMC development experience in either Drug Product, Drug Substance or Analytical Sciences with a proven track record spanning pre‑IND to NDA/BLA submission and experience across the important geographic areas (mainly US, EU, JP).
Proven track record of successfully leading the development of regulatory CMC strategies for all stages of drug development, producing high‑quality regulatory submissions, and leading successful interactions with regulatory agencies.
Location and Work Model This is not a remote role. We work together and operate in a hybrid model in office Tuesday, Wednesday & Thursday each week.
Compensation The estimated full‑time salary range for this role is between $236,000 to $309,000. The final compensation package 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 discretionary annual bonus, equity, health insurance (medical, dental, 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.
Seniority Level Director
Employment Type Full‑time
Job Function Sales, General Business, and Education
Industries Wireless Services, Telecommunications, and Communications Equipment Manufacturing
#J-18808-Ljbffr
As an integrated member of the PepGen Team you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the development and life‑cycle management of investigational products, including risk management and compliance requirements, authoring, compiling and/or reviewing CMC modules for regulatory submissions for investigational new drugs, clinical trial applications, and meeting briefing documents and responses to health authority queries.
In addition, working closely with our CMC and Quality organization, you will provide valuable regulatory support on technical and quality activities, such as manufacturing process development, specifications, in‑process controls, stability protocols, and change control management, and product and compliance quality initiatives.
About the Team As a member of this team, you will feel the excitement, passion, and pure joy that comes from being part of an innovative company with a focused mission.
Responsibilities
Command the attention and lead higher level managers and senior subject matter experts.
Demonstrate leadership, problem‑solving abilities, flexibility, and foster strong team relationships, with excellent written and oral communication skills.
Be independently motivated, possess effective analytical and problem‑solving skills, with the ability to navigate complex clinical regulatory challenges.
Maintain a detail‑oriented mindset and exceptional organizational skills, adapting to dynamic and evolving regulatory landscapes.
Requirements
Bachelor’s degree at a minimum, preferably a PhD in a Life Science area (or equivalent experience).
In-depth knowledge of regulatory guidelines and requirements for the development and manufacturing of pharmaceutical products, preferably with nucleic acid‑based therapies.
Hands‑on CMC development experience in either Drug Product, Drug Substance or Analytical Sciences with a proven track record spanning pre‑IND to NDA/BLA submission and experience across the important geographic areas (mainly US, EU, JP).
Proven track record of successfully leading the development of regulatory CMC strategies for all stages of drug development, producing high‑quality regulatory submissions, and leading successful interactions with regulatory agencies.
Location and Work Model This is not a remote role. We work together and operate in a hybrid model in office Tuesday, Wednesday & Thursday each week.
Compensation The estimated full‑time salary range for this role is between $236,000 to $309,000. The final compensation package 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 discretionary annual bonus, equity, health insurance (medical, dental, 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.
Seniority Level Director
Employment Type Full‑time
Job Function Sales, General Business, and Education
Industries Wireless Services, Telecommunications, and Communications Equipment Manufacturing
#J-18808-Ljbffr