NKGen Biotech, Inc. is seeking an experienced and motivated individual to fulfill the role of Senior Manager/Associate Director, Regulatory Affairs CMC. The successful candidate will be responsible for serving as the Regulatory CMC Lead for the assigned company’s cell therapy program(s). Key responsibilities for this position include leading the preparation of CMC sections of regulatory submissions, interacting with global regulatory authorities on manufacturing development, and providing relevant guidance to cross-functional teams to ensure that all applicable regulatory requirements are appropriately met.
Candidates must be based in Southern California or willing to relocate for the position.
- Serve as the Regulatory CMC Lead for early-stage cell therapy program(s). Drive the preparation (authorship and compilation) and facilitate the review of CMC sections of regulatory submissions. In coordination with Regulatory Affairs program Lead, develop regulatory strategies for global CMC submissions.
- Ensure that products are manufactured to the standards and specifications outlined in the regulatory documents.
- Support the Manufacturing team by providing regulatory strategies for the development of the company’s novel cell therapies products.
- Perform regulatory gap analysis of available CMC documents against regulatory requirements and plan appropriate remediation strategies.
- Represent Regulatory Affairs CMC in meetings with regulatory authorities on the topics relating to the manufacturing of the product(s). Prepare appropriate meeting materials as required.
- Provide regulatory guidance and input to cross-functional teams as needed. Update the team on new regulatory requirement(s).
- Perform regulatory intelligence and monitor the impact of new regulations. Stay abreast on CMC and GMP regulations.
- Maintain positive work environment with colleagues and external partners.
- Perform other duties as assigned.
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- BS/BA degree in biological science field or related scientific discipline, with a minimum of 10 years in the biotechnology/pharmaceutical industry. Advanced degree preferred.
- Minimum of 5 years of experience in Regulatory Affairs CMC in the biotechnology or pharmaceutical industry for Senior Manager, or a minimum of 8 years of experience for Associate Director. Experience with cell therapy product is desirable.
- Thorough understanding of regulatory CMC requirements relevant to global drug development. Strong knowledge of U.S. federal regulations related to GMP.
- Prior experience in managing regulatory submissions with the ability to successfully manage projects to deadlines. Successful track record of filing of INDs/CTAs, NDAs/BLAs/MAAs, meeting requests/meeting information package, and other pertinent regulatory documents.
- Prior experience in a product development role.
- History of achieving regulatory goals in ambiguous and challenging situations.
- Proven ability to successfully interact with regulatory authorities.
- Proven ability to manage critical projects as a part of an interdisciplinary team.
- Strong knowledge of electronic document and submission standards. Experienced in eCTD publishing.
- Detailed oriented with outstanding interpersonal and communication (written and verbal) skills.
- Strong organizational skills
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!