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PepGen is at an exciting time in our development. This role is the first, full-time regulatory CMC employee at PepGen, providing a unique opportunity 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
Requirements
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.
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.
PepGen does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Pepgen from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Pepgen and do not obligate Pepgen to pay fees if we hire from those resumes.
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.
Full Time
$175k-233k (estimate)
11/01/2023
04/28/2024
pepgen.com
Alameda, CA
<25
The following is the career advancement route for Director, Regulatory CMC positions, which can be used as a reference in future career path planning. As a Director, Regulatory CMC, it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director, Regulatory CMC. You can explore the career advancement for a Director, Regulatory CMC below and select your interested title to get hiring information.