Head of Regulatory Affairs "Remote"

Company: Meet
Location: Nashville
Posted on: January 16, 2022

Job Description:

SummaryThis director of regulatory affairs will be a crucial member of a fast-paced regulatory affairs team that works with building strong relationships and advocacy with the FDA and other international regulatory authorities. This leadership role will necessitate the oversight of CROs for preparing regulatory submissions and interaction with essential member of the project teams and agencies/health authorities to maintain product approvals. This Director role reports to the Chief Operating Officer.
Job Description

• Lead and implement global regulatory strategy
• Act as primary strategic contact with the US FDA, EMA and other health authorities
• Provide direct Regulatory oversight to all non-clinical, clinical and CMC activities Skills Required
  • Bachelor's degree in scientific discipline, advanced scientific degree preferred.
  • 12+ years of pharmaceutical industry experience with 10 years in Regulatory affairs. Global experience desired
  • Experience in multiple phases of development in different therapeutic areas. Oncology experience is a plus
  • Understanding of everything on the regulatory affairs side of things and ability to translate that information to be helpful with others that join the regulatory group down the line

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