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Head of Regulatory Affairs

The major functions to be performed in this position are as follows:
• Develops regulatory strategies to expedite FDA review and approval of drug submissions in conjunction with EVP of Development
• Leads preparation and interactions (e.g., IND, pre-NDA/BLA, EOP2 meetings, advisory committee meetings, etc.) with the FDA and other foreign health authorities (e.g. Canada, EU) on behalf of all Progenics development programs and products
• Oversees regulatory operations, coordinates and directs the resources in preparation of and timely submissions to the FDA and other health authorities in support of development programs
• Maintains regulatory compliance for INDs, CTAs and NDAs/MAAs
• Cross-functionally partners with colleagues in to manage regulatory activities in preparation of submissions and translate regulatory requirements into pragmatic and strategic strategies and plans
• Plan, write, and review Health Authority document submissions (e.g. Briefing Documents)
• Develop and manage annual regulatory budget
• Remain well-informed of key global guidance documents, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

Education: Advanced degree in Life Sciences, Ph.D. preferred
Experience: Candidates should have a minimum of 10-15 years of experience in pharmaceutical drug development as a regulatory lead.

• Proven track record of successfully bringing new product candidates to the market through approval and commercialization
• Thorough understanding of drug development process and FDA regulations is required
• Experience in late stage development programs, post-approval and commercial experience is required
• Experience or familiarity with radiopharmaceuticals products is highly desirable
• Ability to work in a fast-paced environment among competing priorities
• Experience or familiarity with diagnostics, radionuclide therapies and medical devices (e.g. 510k) is also desirable
• Familiarity with senior personnel in the FDA drug divisions a plus
• Strong problem solving, negotiation, attention to detail and multi-functional team leadership skills
• Ability to build cross-functional relationships across the company including Development and Legal & Compliance
• Excellent oral and written communication skills a must