Remote Senior Regulatory Affairs Manager, Gene Therapy

Encoded Therapeutics, Inc.; Northern (KY); Hybrid; USD 142,000 - 164,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

PTO & holidays

Parental Leave

Pre-tax benefits

Fitness center

Job summary

Encoded Therapeutics, Inc. is seeking a Manager of Regulatory Affairs to advance clinical regulatory strategy for ETX-301 and contribute to ex-US activities for ETX-101.

The role drives US and EU submissions, supports global health authority interactions, and works across clinical, CMC, and quality teams in a fast-paced biotech setting. Ideal candidates have cell/gene therapy experience, strong clinical regulatory background, and exposure to European regulatory pathways.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biology, or related field.
• Minimum 8 years with a BA; 6 years with an MSc; or a PhD with 3+ years.
• Strong understanding of FDA and global regulatory requirements for biologics or gene therapy.
• Experience in preparing and maintaining routine IND/CTA filings and safety reporting outputs.
• Experience in rare disease, cell therapy, or gene therapy preferred.

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 for adult neuropathic pain and CNS-targeted gene therapy.
• Prepare, review, and coordinate regulatory submissions (IND/IMPD amendments, briefing packages, health authority responses).
• Support interactions with US and ex-US health authorities (FDA, EMA and national agencies).
• Collaborate with Clinical Development, CMC, Quality, and other cross-functional teams to integrate regulatory requirements into program plans.

Skills

FDA regulatory knowledge

Regulatory strategy

Cross-functional collaboration

Technical writing

eCTD knowledge

IND/CTA filings

Education

Bachelor’s or Master’s degree in Life Sciences

Job description

Encoded Therapeutics, Inc. is seeking a Manager of Regulatory Affairs to advance clinical regulatory strategy for ETX-301 and contribute to ex-US activities for ETX-101.

The role drives US and EU submissions, supports global health authority interactions, and works across clinical, CMC, and quality teams in a fast-paced biotech setting. Ideal candidates have cell/gene therapy experience, strong clinical regulatory background, and exposure to European regulatory pathways.