Director of Regulatory Affairs

2 days ago


Gaithersburg MD USA, United States Proclinical Staffing Full time
Director, Global Regulatory Affairs, Development Strategy

Proclinical is seeking a seasoned professional to lead our client's global regulatory affairs and development strategy efforts.

Key Responsibilities:

  • Develop and implement a comprehensive US regulatory development strategy to ensure successful registration and life-cycle management of complex products.
  • Provide strategic regulatory advice for global product development, including pre-approval and marketed compounds.
  • Lead major submissions and FDA meetings, ensuring effective communication and collaboration with cross-functional teams.
  • Collaborate with management, Global Regulatory Lead, and cross-functional colleagues to provide regulatory guidance and support.
  • Represent the company as point contact for FDA and lead company delegation for regulatory authority meetings.

Requirements:

  • Bachelor's Degree in a related discipline.
  • Strong knowledge of US drug development and regulatory policy, with excellent scientific and business judgment.
  • Experience providing US strategic regulatory advice for global product development, including pre-approval and marketed compounds.
  • Experience leading major submissions and FDA meetings.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. We are an equal opportunity employer.



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