Director, Regulatory Affairs-Global Regulatory Lead

Responsibilities: Provide regulatory leadership for assigned development projects; develop regulatory scientific/tactical strategy, regulatory intelligence, and agency liaison. Lead US and ex-US regulatory activities with global in-house/outsourced sites. Establish and maintain relationships with FDA; oversee submissions to EMA, MHRA, and other Health Authorities. Develop regulatory plans and target labeling to support product development. Lead creation and writing of regulatory submission documents (briefing documents; IND/CTA supporting documents; labeling; CTD/BLA/MAA for eCTD submissions). Manage and coordinate preparation and submission of regulatory documentation (CTA/INDs, BLAs/MMAs, CTA safety reports/updates, and other filings). Serve as global center of excellence for regulatory requirements/guidelines; monitor regulatory environment for oncology, antifectives, autoimmune diseases, and biologics. Contribute to procedures/work practices for late-stage development and commercialization. Oversee regulatory review of clinical trial labeling and CMC submissions (with Director of Regulatory CMC). Ensure quality and clarity of scientific/technical information and evidence for conclusions. Qualifications (Essential): Solid drug development leadership track record in dynamic teams. Strong scientific background; emerging ability to develop regulatory scientific strategies. Strong global regulatory knowledge; excellent US regulatory expertise with submission experience. Experience supporting global clinical studies. Experience managing/preparing/submitting INDs/CTAs, BLAs/NDAs, MAAs; at least 1 NME BLA/NDA highly desirable. Experience preparing for and conducting Health Authority Meetings (FDA required); maintain ongoing liaison. Agile mindset; proven leadership, communication, and interpersonal skills. Advanced degree preferred (M.S./PharmD/Ph.D./M.D.) with 5–10 years’ experience, or BS with 8–12 years’ experience. Position: Full-time, exempt; occasional overtime; limited overnight and occasional local day travel. #J-18808-Ljbffr