Clinical Regulatory Affairs Lead (FDA)

Job description Elpida Therapeutics is a mission-driven 501c3 Non-Profit biotechnology startup developing gene therapies, gene editing, ASOs, and cell therapies for patients with serious unmet medical needs. We are seeking an experienced Regulatory Affairs professional to help lead US regulatory strategy across our development programs. This is a unique opportunity to play a central role in advancing innovative therapies from development through key regulatory milestones in a fast-paced, hands-on environment. Preferred Qualifications (Not Required) • Living in California • Worked at the FDA Key Requirements • Direct FDA / IND experience required • Gene or cell therapy experience required • BLA submission experience required • Strong clinical regulatory experience required • Biologics experience required • MHRA and EMA experience (Ideal but not needed) • Experience with AAV-based gene therapy strongly preferred • Must live in the USA What You’ll Do • Serve as the US regulatory lead for assigned programs • Develop and execute regulatory strategies across preclinical, clinical, and registration stages • Lead and contribute directly to the drafting of IND documents and related submission components • Help develop clinical trial strategy and design in collaboration with internal teams and external KOLs, including: • clinical endpoints • schedule of events • immunosuppression approach • Support development of multi-site clinical trial strategies, including coordination across sites and alignment of regulatory plans • Lead preparation and submission of regulatory documents including: • INDs and amendments • agency meeting requests and briefing packages • designation applications such as Fast Track, RMAT, and PRIME • registration submissions such as BLA and MAA • Lead or participate in interactions with FDA and other health authorities • Partner closely with cross-functional teams, external CROs, investigators, and subject matter experts • Support global development efforts in collaboration with EU regulatory colleagues • Contribute directly to the writing, editing, and review of regulatory submission components • Help ensure regulatory compliance, SOP development, and high-quality execution across programs What We’re Looking For • BS, MS, or higher degree in a scientific discipline • 7+ years of regulatory experience required, with 10+ years preferred • Experience in gene therapy, cell therapy, gene editing, ASOs, and/or biologics • Strong experience supporting clinical development strategy • Ability to work in a hands-on, fast-moving startup environment • Strong writing, communication, collaboration, and problem-solving skills • A patient-centric, mission-driven mindset and willingness to roll up your sleeves to get the job done Preferred Experience • AAV-based gene therapy • CMC regulatory exposure • Gene editing, allogeneic platforms, and/or CAR-T • EMA, MHRA, and broader ex-US regulatory strategy (Helpful) • Experience with multi-site trial execution • Device or companion diagnostics experience is a plus At Elpida, you’ll have the opportunity to help shape regulatory strategy for transformative therapies that can change lives. Pay: $120,000.00 - $220,000.00 per year Benefits: • 401(k) • 401(k) matching • Dental insurance • Flexible schedule • Health insurance • Life insurance • Paid time off • Retirement plan • Vision insurance Application Question(s): • Are you based out of California? • Have you worked on a BLA • Do you have experience building and submitting MHRA or EMA applications • What is your ideal salary expectations (This position does not pay a bonus) Work Location: Remote