Manager, Regulatory Affairs (Gene Therapy)

Encoded Therapeutics Inc.; United States; Presencial; USD 142 000 - 177 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Parental Leave

Resumo da oferta

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.

Qualificações

• 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

Responsabilidades

• 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

Conhecimentos

Regulatory strategy

FDA regulations

Global submissions

GXP/ICH

Technical writing

Cross-functional collaboration

Formação académica

Bachelor's degree in Life Sciences

Master's degree in related field

PhD (optional)

Ferramentas

eCTD management systems

Regulatory submission software

Descrição da oferta de emprego

Description

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

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 and support for global health authority interactions.

Requirements

• 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)

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. Actual compensation will be determined based on relevant skills, experience, qualifications, internal equity, and business needs. 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

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at [phone].