Remote Regulatory Affairs Manager — Gene Therapy

Encoded-Therapeutics,-Inc.; South San Francisco (CA); Hybrid; USD 142.000 - 177.000; Vollzeit

Benefits dieser Stelle

Competitive benefits

Stock options

PTO & holidays

Parental leave

Pre-tax health care

Discretionary bonus

Micro-kitchen

Fitness center

Zusammenfassung

Encoded Therapeutics Inc. is seeking a Manager, Regulatory Affairs to lead regulatory strategy for ETX-301 and support ETX-101. This US-based remote role reports to regulatory leadership and works cross-functionally in a fast-paced biotech environment.

You will drive day-to-day regulatory activities, prepare submissions (IND/IMPD amendments), coordinate health authority interactions, and ensure compliant documentation across US and EU programs, with West Coast preference for location.

Qualifikationen

• 8+ years of related regulatory affairs experience with a bachelor’s degree; or 6 years and a Master’s; or a PhD with 3 years’ experience.
• Strong understanding of FDA and global regulatory requirements for biologics or gene therapy.
• 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.
• Excellent organizational, project management, technical writing and communication skills.

Aufgaben

• Drive day-to-day execution of regulatory activities for ETX-301 and supporting work on ETX-101.
• Contribute to clinical regulatory strategy, particularly for adult neuropathic pain and CNS-targeted gene therapy.
• Prepare, review, and coordinate regulatory submissions (IND/IMPD amendments, briefing packages, responses to health authority questions).
• Support interactions with US and ex-US health authorities, including meeting materials and follow-up.
• Partner with cross-functional teams to ensure regulatory requirements and timelines are integrated into program plans.

Kenntnisse

Regulatory affairs

Clinical development

Regulatory writing

Cross-functional collaboration

Ausbildung

Bachelor's degree in Life Sciences

Master's degree in a relevant field

PhD

Tools

CRO management

Jobbeschreibung

Encoded Therapeutics Inc. is seeking a Manager, Regulatory Affairs to lead regulatory strategy for ETX-301 and support ETX-101. This US-based remote role reports to regulatory leadership and works cross-functionally in a fast-paced biotech environment.

You will drive day-to-day regulatory activities, prepare submissions (IND/IMPD amendments), coordinate health authority interactions, and ensure compliant documentation across US and EU programs, with West Coast preference for location.