Director, Regulatory Affairs - CMC

Director, Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls) Responsibilities Work collaboratively on development and execution of Regulatory-CMC strategies for gene therapy products. Develop, propose, and execute global Regulatory-CMC strategy for gene therapy products from early development to licensure. Lead the preparation/review of CMC submission documents, registration dossiers, and responses to health authorities (e.g., briefing packages; IND/IMPD; BLA; MAA regulatory filings). Serve as the CMC Regulatory lead in Health Authority interactions and meetings. Coordinate with cross-functional CMC, analytical, quality, and regulatory teams to create high-quality submissions. Represent CMC regulatory strategy at cross-functional Global Project Team, Change Management team, and governance meetings. Ensure CMC submissions are complete, accurate, and meet regulatory requirements, including data integrity, quality standards, and regulatory guidelines. Drive Regulatory-CMC strategy for product development plans, manufacturing changes, and quality control processes to ensure compliance and mitigate regulatory risks. Advise on policy changes and whether/when to engage externally. Oversee development/implementation of internal policies and procedures to ensure compliance with regulatory requirements and industry best practices. Identify and assess potential CMC regulatory risks and develop mitigation strategies across pipelines. Qualifications Minimum BS degree; advanced degree preferred (PharmD/Ph.D. or equivalent) in a relevant scientific discipline. 12 years Regulatory Affairs experience required (minimum 8 years with an advanced degree), preferably in the pharmaceutical industry. At least 8 years of CMC regulatory strategy experience required. Experience with biotechnology and/or gene therapy products strongly preferred. Experience interfacing and responding to global regulatory authorities, especially for gene therapy products. Knowledge of US, EU, and international regulations and ICH guidelines related to CMC gene therapy development. Experience preparing CMC content for major global submissions (INDs, CTAs, license applications, meeting briefing packages). Ability to thrive in a fast-paced environment; strong strategic and tactical skills. Excellent written/verbal communication and analytic/problem-solving skills. Compensation Expected salary range: $204,000 to $244,000. Total rewards may include bonuses (short-term incentives), medical/dental/vision, life insurance, 401(k) with company match and generous vesting, paid vacation/holidays, global shutdown days, wellness resources, employee support programs, and equity awards (long-term incentives). #J-18808-Ljbffr Scorpion Therapeutics