Director/Senior Director of Global Regulatory Affairs

Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline. 10+ years of regulatory affairs experience in the biopharmaceutical industry. At least 5 years in a leadership role. Proven track record of managing global regulatory submissions (IND/CTA, NDA/BLA, MAA) and lifecycle management. Experience in oncology or biologics preferred; combination product/device experience is a plus. Deep understanding of global regulatory frameworks (FDA, EMA, PMDA, etc.). Familiarity with ICH guidelines, GCP, and evolving regulatory trends. Expertise in regulatory strategy development and execution. Strong document review and submission planning skills. Proficiency with regulatory information management systems and electronic submission platforms (eCTD).

Develop and execute integrated global regulatory strategies for drug and device programs. Manage submission strategies and oversee preparation and delivery of regulatory submissions. Ensure compliance with global laws, regulations, and standards. Coordinate and lead cross-functional teams for regulatory submissions. Monitor regulatory commitments and deliverables across regions.