Develop, oversee and drive global regulatory strategies for assigned development programs and marketed products in US, and other priority markets supported by the regional regulatory teams.
Serve as the senior regulatory lead in interactions with major health agencies including FDA, leading high-stakes negotiations and ensuring high-quality briefing packages and responses.
Partner with R&D, CMC, Manufacturing, Clinical, Medical, Quality, Commercial, and Supply Chain teams to integrate regulatory requirements into global product strategies, development plans, and launch readiness.
Lead, mentor, and develop a global team of regulatory professionals across multiple regions.
Ensure global compliance across development, submissions, registration maintenance, and post-market activities.
Support due diligence activities for partnerships, acquisitions, and in-licensing opportunities by assessing regulatory risks, pathways, and development strategies.

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree strongly preferred.
12+ years of global regulatory affairs experience, including leadership roles with increasing responsibility.
Proven experience navigating US FDA requirements, regulations and pathways including but not limited to experience with Fast Track, Orphan Designation, Priority and Rolling Review.
Strong expertise in Clinical and CMC regulatory strategy, with hands-on experience guiding Clinical and CMC teams through development, registration, and global change management.
Proven experience managing and developing regulatory teams across multiple regions.
Deep understanding of global regulatory frameworks from IND/CTA through marketing approval, post-approval changes, compliance, and pharmacovigilance-related requirements.

Senior Director, Regulatory Affairs, Radiopharma

Key skills