Senior Director, Regulatory Affairs, Radiopharma
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Job Description
Senior Director leading global regulatory strategies and managing multi-regional teams in healthcare. Overseeing regulatory compliance and engaging with health authorities for product approvals.
Responsibilities:
- 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.
Requirements:
- 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.
Benefits:
- medical, dental, vision
- paid time off
- 401(k) plan with employee and company contribution opportunities
- life insurance
- disability insurance
- accident insurance
- tuition reimbursement
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