Clinical Regulatory Affairs reputed company (FDA)

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 reputed company Regulatory Affairs reputed company to help reputed company US regulatory reputed company 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 • reputed company 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 reputed company for assigned programs • reputed company and execute regulatory strategies across preclinical, clinical, and registration stages • reputed company and contribute directly to the drafting of IND documents and reputed company submission components • Help reputed company clinical trial reputed company 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 • reputed company preparation and submission of regulatory documents including: • INDs and amendments • agency meeting requests and briefing packages • designation applications such as Fast reputed company, RMAT, and reputed company • registration submissions such as BLA and MAA • reputed company 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-reputed company execution across programs reputed company’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 reputed company • Ability to work in a hands-on, fast-moving startup environment • Strong writing, communication, collaboration, and problem-solving skills • A patient-reputed company, mission-driven reputed company 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 reputed company (Helpful) • Experience with multi-site trial execution • Device or companion diagnostics experience is a plus At Elpida, you’ll have reputed company to help shape regulatory reputed company for transformative therapies that can change lives. Apply tot his job Apply To this Job