Manager, Regulatory Affairs – Gene Therapy

🔥 6 hours ago

🇺🇸 United States – Remote

💵 $142k - $177k / year

⏰ Full Time

🟠 Senior

🔴 Lead

😶‍🌫️ Therapist

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Encoded Therapeutics Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Encoded Therapeutics Inc. is a biotechnology company focused on developing innovative genetic medicines to address central nervous system (CNS) disorders. Their work aims to tackle the root causes of these disorders, providing potentially transformative, long-lasting therapies designed to improve patient outcomes and quality of life, particularly for conditions such as Dravet Syndrome and Angelman Syndrome. The company uses a unique targeting and regulation platform allowing for increased gene specificity and cell selectivity, overcoming challenges associated with first-generation gene therapies. Encoded Therapeutics is dedicated to translating cutting-edge science into practical, life-changing solutions for patients worldwide.

📋 Description

• 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

• 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

• 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