Manager, Regulatory Affairs (Gene Therapy)
New
E
Encoded Therapeutics Inc.Biotechnology
United States, West Coast preferred but not requiredFull-TimeManager
SalaryFor candidates based in the SFBA area, the salary range for this position is 156,000 - 177,000. For candidates based outside the SFBA area, the salary range is 142,000 - 164,000.
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Job Details
- Experience
- A minimum of 8 years of related experience with a bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years’ experience
- Required Skills
- Project Management
Requirements
- Bachelor's or Master's degree in a scientific discipline (Life Sciences, Biotechnology, Biology, or related field).
- A minimum of 8 years of related experience with a bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years’ experience.
- Strong understanding of FDA and global regulatory requirements for biologics or gene therapy products.
- Solid working knowledge of drug development processes, eCTD standards, and GXP/ICH requirements.
- Hands-on experience preparing and maintaining routine IND/CTA filings and safety reporting outputs.
- Strong organizational, project management, technical writing, and communication skills.
- Experience in rare disease, cell therapy, or gene therapy is highly preferred.
- Experience specifically focused on AAV gene therapy or rare diseases.
- Direct experience interacting with cross-functional teams, CROs, and regulatory vendors.
- Familiarity with expedited regulatory pathways (e.g., RMAT, Breakthrough Therapy, Orphan Drug designations).
Responsibilities
- Drive day-to-day execution of regulatory activities for ETX-301 and supporting work on ETX-101 and other gene therapy programs.
- Contribute to clinical regulatory strategy, particularly for adult neuropathic pain and CNS-targeted gene therapy.
- Prepare, review, and coordinate regulatory submissions such as IND/IMPD amendments, briefing packages, and responses to health authority questions.
- Support interactions with US and ex-US health authorities, including preparing meeting materials and follow-up.
- Partner with Clinical Development, Clinical Operations, CMC, and Quality teams to ensure regulatory requirements are integrated into program plans.
- Monitor, interpret, and communicate relevant global regulatory guidelines in gene therapy and neurology/pain.
- Contribute to risk identification, mitigation planning, and issue resolution from a regulatory perspective.
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