Regulatory Affairs Associate Director or Director

My client is a biopharmaceutical company developing novel therapeutics.  In this role you will provide input and regulatory support to cross-functional development teams.  This is a unique opportunity to get in on the ground floor of a well-funded, innovative organization with breakthrough potential for patients.

Responsibilities:

  • Define and execute regulatory strategies in support of overall program goals and objectives
  • Provide day-to-day management of all regulatory aspects of ongoing and planned clinical development programs
  • Contribute to product and development teams as a key regulatory voice, providing regulatory guidance
  • Lead the coordination, preparation and timely submission of regulatory documents and responses to queries from authorities
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements

Knowledge and Skills:

  • Bachelor degree in a scientific field is required. Advanced degree preferred
  • A minimum of 7-12 years of hands-on regulatory drug development and project team experience
  • Direct regulatory filing experience required;
  • Strong project management skills, with a track record of leading teams to deliver high impact results required;
  • Excellent strategic and analytical thinking capabilities with strong communications

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