Manager, Regulatory Affairs; Gene Therapy

Department:

Regulatory

Locations:

United States

Type:

Full time

Req#:

LRP-

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit  .

The Manager, Regulatory Affairs, will play a hands-on, execution-focused role supporting clinical regulatory strategy for ETX-301 in neuropathic pain and contributing to ex-US efforts for ETX-101. This individual will drive day-to-day regulatory activities for clinical-stage gene therapy programs, including preparation and coordination of US and EU submissions and support for global health authority interactions.

The ideal candidate brings industry experience in cell and/or gene therapy, a strong foundation in clinical regulatory strategy (vs. purely CMC), and preferably exposure to European regulatory pathways, adult neurology, pain, and/or device or in vitro diagnostic interfaces. This is a US-based remote role (West Coast preferred but not required) reporting into the regulatory leadership team and working cross-functionally in a fast-paced, growing biotech environment.

Requirements

• 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 (e.g., IND/IMPD amendments, briefing packages, responses to health authority questions).
• Support interactions with US and ex-US health authorities (e.g., FDA, EMA and relevant national agencies), including meeting materials and follow-up.
• Partner closely with Clinical Development, Clinical Operations, CMC, Quality, and other cross-functional teams to ensure regulatory requirements and timelines are integrated into program plans.
• Monitor, interpret, and communicate relevant global regulatory guidelines and expectations in gene therapy and neurology/pain.
• Contribute to risk identification, mitigation planning, and issue resolution from a regulatory perspective.
• Ensure high-quality, consistent messaging and documentation across regulatory submissions and internal stakeholders.
• Maintain accurate tracking, documentation, and archival of regulatory submissions and correspondence.
• Qualifications
• 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; or equivalent 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.
• Experience in rare disease, cell therapy, or gene therapy is highly preferred.
• Strong organizational, project management, technical writing and communication skills.
• Preferred Qualifications
• 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).

For candidates based in the SFBA area, the salary range for this position is 156,000 – 177,000

For candidates based outside the…