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  Ability to be able to command the attention and lead higher level managers and senior subject matter experts.  Demonstrated leadership, problem-solving abilities, the ability to be flexible, and foster strong team relationships, with excellent written and oral communication skills.  Independently motivated, effective analytical and problem-solving skills, with the ability to navigate complex clinical regulatory challenges.  Detail-oriented mindset and exceptional organizational skills, augmented with adaptability to dynamic and evolving regulatory landscapes.  Requirements  Bachelor’s degree at a minimum, preferably a PhD in a Life Science area (or equivalent experience).

An 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)  A 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.  Note :

• This is not a remote role.
• We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.
• Compensation The estimated full-time salary range for this role is between $236,000 to $309,000.
• 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.   About PepGen PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.
• PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics.
• Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.
• For more information, please visit PepGen.com.
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• EEO Statement PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce.
• All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
• Recruitment & Staffing Agencies PepGen does not accept unsolicited agency resumes.
• The company will not be responsible for any fees related to resumes that are unsolicited.
• Thank you.
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