[Hiring] Manager, Regulatory Affairs @Encoded Therapeutics

Role Description

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
• 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, 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.

• 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).

Requirements

• For 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.
• Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location.
• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

Benefits

• Comprehensive benefits package, including competitive employer premium contributions.
• Meaningful stock option grants.
• PTO, sick time and holiday pay.
• Generous Parental Leave program.
• Pre-tax medical and dependent care programs.
• STD, LTD, Life and AD&D.
• Professional development opportunities.
• Team-building events.
• Fully stocked micro-kitchen.
• Fitness center at South San Francisco location.