Regulatory Affairs Manager, Gene Therapy

Encoded Therapeutics Inc.; United States; On-site; USD 142,000 - 177,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Parental Leave

Job summary

Encoded Therapeutics Inc. is seeking an experienced Manager, Regulatory Affairs to drive regulatory execution for gene therapy programs ETX-301 and ETX-101. You will coordinate US and EU submissions and support interactions with health authorities.

You will partner with Clinical Development, CMC, Quality, and other teams to ensure regulatory requirements are integrated into program plans, and help navigate global guidelines for rare diseases and CNS targets.

Qualifications

• Drive day-to-day regulatory activities for ETX-301 and supporting work on ETX-101
• Contribute to clinical regulatory strategy for adult neuropathic pain and CNS gene therapy
• Prepare, review, and coordinate regulatory submissions (IND/IMPD, etc.)
• Support interactions with US and ex-US health authorities (FDA, EMA) and meeting materials
• Partner with Clinical Development, CMC, Quality, and other teams to align regulatory timelines
• Monitor global regulatory guidelines for gene therapy and neurology
• Contribute to risk identification, mitigation planning, and issue resolution from a regulatory perspective
• Ensure high-quality, consistent messaging and documentation for submissions
• Maintain tracking and archival of regulatory submissions and correspondence

Responsibilities

• Drive day-to-day regulatory activities for ETX-301 and ETX-101
• Coordinate US and EU submissions and health authority interactions
• Collaborate with cross-functional teams to integrate regulatory requirements into program plans
• Summarize regulatory strategy and prepare briefing materials for health authorities

Skills

Regulatory strategy

FDA regulations

Global submissions

GXP/ICH

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Master's degree in related field

PhD (optional)

Tools

eCTD management systems

Regulatory submission software

Job description

Encoded Therapeutics Inc. is seeking an experienced Manager, Regulatory Affairs to drive regulatory execution for gene therapy programs ETX-301 and ETX-101. You will coordinate US and EU submissions and support interactions with health authorities.

You will partner with Clinical Development, CMC, Quality, and other teams to ensure regulatory requirements are integrated into program plans, and help navigate global guidelines for rare diseases and CNS targets.