Regulatory Affairs Sr. Director/US Lead

Our client is a successful global biotechnology company which is developing medicines for the treatment of debilitating neurological and neurodegenerative diseases.  They are seeking a Regulatory Affairs Sr. Director/US Lead to develop the US regulatory strategy for products in development and commercialized products. With ten approved products and a strong clinical pipeline, this is a great place to advance your career while helping to improve patients’ lives.

Responsibilities:

  • Develop US regulatory strategies for clinical development programs and approved products
  • Work closely with the Global Regulatory Lead and participate on cross-functional project teams
  • Present the US regulatory position to senior management governance committees as needed
  • Responsible for submissions to the FDA including INDs and/or marketing applications
  • Interact directly with the FDA and ensure communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps
  • Ensure that Core label changes are appropriately conveyed in US product labeling
  • Serve as a core member of a Regulatory Product Team and represent the US Business when a global strategies are being discussed and developed
  • Provide regulatory due diligence assessments of new business opportunities as required
  • Mentor and work with junior staff supporting the programs
  • Represent the US regulatory position to senior management governance committees as needed

 

Knowledge and Skills:

  • BA/BS degree in life sciences with MS/PhD/PharmD preferred
  • A minimum of 10+ years of pharmaceutical industry experience with seven+ years in regulatory affairs
  • Well-versed in regulatory strategy and regulatory science writing
  • Experience filing INDs. BLA/MAA/NDA experience is a plus
  • Demonstrated experience in FDA interactions and FDA meeting preparation
  • A strong knowledge of FDA and regulations relevant to the development and approval of new therapeutic agents, biologics, and/or vaccines
  • Experience with late stage development/marketed products
  • Ability to work independently and thrive in a fast-paced environment
  • Excellent project management and writing skills, as well as a good understanding of the underlying science
  • Excellent communication skills and ability to influence across multiple functions
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks

 

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