Director, Regulatory CMC

About our client Our client is a clinical-stage biotech developing AAV gene therapies for rare, life-threatening neuromuscular and cardiac diseases. The company has a strong patient focus. It is moving its lead programs toward pivotal development, registration and commercial launch, and is growing its Regulatory CMC team for that next stage. The role As Director, Regulatory CMC, you’ll own global CMC regulatory strategy across the AAV portfolio. You’ll be the regulatory voice within Technical Operations and Quality and work closely with Program Leadership and the executive team. You’ll also lead CMC discussions with health authorities worldwide. Here, Regulatory CMC is a respected technical partner, not just a submissions function. What you’ll do Build and execute global Regulatory CMC strategies for clinical and late-stage programs, and represent CMC on cross-functional development and governance teams Lead CMC planning for marketing applications (BLA/MAA) and geographic expansion: control strategies, validation, potency methods and commercial specifications Guide manufacturing changes, comparability, tech transfer and network expansion across internal and external manufacturing sites Act as CMC lead for FDA, EMA, MHRA, PMDA, Health Canada and other agencies: briefing packages, responses and meeting strategy Turn changing guidance for advanced therapies into practical program strategy, and advise executives on regulatory risk Shape post-approval lifecycle strategies that keep operations flexible while staying compliant Help build the Regulatory CMC function as the company moves toward commercial stage, and represent it in industry consortia and gene therapy working groups What you bring BS, MS, PhD or PharmD in a scientific discipline 12+ years in Regulatory Affairs, with substantial Regulatory CMC responsibility for biological products (required)A track record leading global CMC strategy for biologics, including registration-enabling programs and marketing applications Hands-on experience leading FDA and/or EMA interactions Strong knowledge of GMP manufacturing, process validation, analytical development, comparability and quality systems Experience leading cross-functional teams in a fast-moving biotech Strongly preferred Direct AAV gene therapy experience: vector characterization, potency assays, comparability and commercial manufacturing strategy BLA preparation, review and post-approval lifecycle management EU development strategy, including scientific advice and commercial readiness Experience with pre-approval inspections and launch readiness Background in rare genetic disease programs, ideally neuromuscular Experience in a company moving from clinical to commercial stage What’s on offer Base salary of $230,000–$260,000, plus annual cash bonus and long-term equity Comprehensive medical, dental and vision coverage, with FSA/HSA options 401(k) with company match and an employee stock purchase plan 15 days PTO with rollover, 12 holidays, a floating holiday and a winter shutdown Tuition reimbursement and a range of wellbeing benefits #J-18808-Ljbffr