Senior Director, Regulatory Affairs

Role: Senior Director, Global Regulatory Affairs, leading regulatory strategy for rare disease clinical development programs. Responsibilities: develop and oversee global regulatory strategies, lead Regulatory Project Teams, manage regulatory documentation and submissions (IND, NDA, MAA), ensure compliance across regions, contribute to health authority interactions, and provide guidance throughout product lifecycle. Requirements: Bachelor's or Master’s in biological sciences, with at least 15 years in pharma, including 12+ years in Global Regulatory Affairs, extensive experience with US FDA, EMA, and Health Canada, and familiarity with major regulatory submissions and guidelines. High-Value: expertise in rare diseases, global regulatory compliance, IND/NDA/MAA submissions, health authority negotiations, and cross-functional collaboration in clinical, CMC, and safety teams. Work setup: onsite at headquarters (minimum 2 days/week), with 10-15% domestic/international travel.