Director/Senior Director, Regulatory

Tarrytown, NY (Current location) and NYC (effective August 1, 2016)

DUTIES – RESPONSIBILITIES:

  • The major functions to be performed in this position are as follows:
  • 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)
  • Leads interactions with the FDA and other foreign health authorities (e.g. Canada, EU) on behalf of all the company’s development programs and products
  • Develops regulatory strategies to expedite FDA review and approval of drug submissions in conjunction with EVP of Development

QUALIFICATIONS:

  • Education: Ph.D. in Life Sciences
  • Experience: Candidates should have a minimum of 7-10 years of experience in pharmaceutical drug development as a regulatory lead.

TECHNICAL SKILLS:

  • Proven track record of successfully bringing new products to the clinic through approval and commercialization
  • Thorough understanding of drug development process and FDA regulations is required
  • Experience in late stage development programs, radiopharmaceuticals, post-approval and commercial experience is required
  • Experience or familiarity with radiopharmaceuticals products and/or breakthrough designation is highly desirable
  • Experience or familiarity with medical devices (e.g. 510k) is also desirable
  • Familiarity with senior personnel in the FDA drug divisions a plus
  • Strong problem solving, negotiation, 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

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