Senior Director, Regulatory CMC
Please ensure you read the below overview and requirements for this employment opportunity completely.
PepGen is at an exciting time in our development. This role is for a motivated and team-oriented 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 command the attention and lead higher-level managers and senior subject matter experts.
- Demonstrated leadership, problem-solving abilities, flexibility, and 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 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.
About PepGen
We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform.
We are applying this technology across a wide range of indications and are rapidly growing our team at our U.S. headquarters in Boston, Massachusetts.
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