Manager, Regulatory Affairs – Gene Therapy

Encoded Therapeutics Inc.

. Drive day-to-day execution of regulatory activities for ETX-301 and supporting work on ETX-101 and other gene therapy programs .

Posted 9/24/2026full-timeRemote • United StatesSeniorLead💰 $142,000 - $177,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory activities for gene therapy, including IND/IMPD submissions and interactions with health authorities. Possesses strong project management, technical writing, and communication skills, with a focus on compliance with FDA and global regulatory requirements.

Highest-signal resume keywords

Regulatory SubmissionsFDA Regulatory RequirementsGene Therapy ExpertiseProject ManagementTechnical Writing

ATS Keywords

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Hard Skills

IND/IMPD SubmissionsECTD StandardsGXP/ICH RequirementsDrug Development ProcessesSafety ReportingRegulatory Risk MitigationAAV Gene TherapyRare Disease ExperienceRegulatory PathwaysClinical Regulatory Strategy

Soft Skills

Organizational SkillsCommunication SkillsCollaborationProblem-SolvingTechnical Writing

Industry Keywords

BiologicsGene TherapyCNS-Targeted TherapyClinical DevelopmentCross-Functional TeamsHealth Authority InteractionsRegulatory GuidelinesClinical OperationsCROsRegulatory Vendors

About the role

Key responsibilities & impact

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, including IND/IMPD amendments, briefing packages, and responses to health authority questions
Support interactions with US and ex-US health authorities, including FDA, EMA, and relevant national agencies
Partner with Clinical Development, Clinical Operations, CMC, Quality, and other cross-functional teams
Monitor, interpret, and communicate global regulatory guidelines and expectations in gene therapy and neurology/pain
Contribute to regulatory risk identification, mitigation planning, and issue resolution
Ensure consistent messaging and documentation across regulatory submissions and internal stakeholders
Maintain accurate tracking, documentation, and archival of regulatory submissions and correspondence
Report into the regulatory leadership team

Requirements

What you’ll need

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
Experience specifically focused on AAV gene therapy or rare diseases is preferred
Direct experience interacting with cross-functional teams, CROs, and regulatory vendors
Familiarity with expedited regulatory pathways (e.g., RMAT, Breakthrough Therapy, Orphan Drug designations)

Benefits

Comp & perks

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
Discretionary annual bonus
Discretionary stock-based long-term incentives