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Director, Regulatory Affairs

Reference Number: 3950
Location: NJ

Our client is a global pharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs.

Major tasks and responsibilities will include:

  • Provides strategic product direction to teams on interaction and negotiate evidence with regulatory agencies.
  • Ensures that pre-clinical and clinical trials designs meet regulatory requirements.
  • Ensures approval of new drugs and continued approved status of marketed drugs or medical devices.
  • Serves as regulatory representative to project teams and regulatory agencies.
  • Negotiates with regulatory agencies and ensures the timely preparation of scientifically valid submissions with highest probability of success and within defined time schedules and in accordance with established standards.
  • Offers expert advice to project teams on technical labeling, manufacturing changes, line extensions, regulations, etc.
  • Supports collaboration development with partners by developing and communicating strategies and aligning on such strategies in advance of execution.
  • Identifies regulatory requirements and develops optimal strategies throughout the drug development and registration process to ensure meeting corporate objectives.
  • Communicates regulatory issues and transmits regulatory concerns to internal teams and senior managements.
  • Continuously evaluates the constantly changing regulatory environment for impact on assigned projects and development programs.
  • Acquires regulatory intelligence concerning competitor products and conveys to project/core teams.
  • Leads and manages staff using good interpersonal skills in the planning, preparation and submission of regulatory application.

We seek candidates with the following qualifications:

  • Bachelor's degree in life/scientific sciences required. Advanced degree highly preferred.
  • Must have a minimum of 10 years of pharmaceutical industry experience, and at least 7 years of regulatory experience.
  • At least 4 years of direct oncology regulatory experience highly preferred.
  • Requires experience with major FDA submissions, and experience dealing with international regulatory agencies and compliance officers.
  • Previous leadership/management experience required.
  • Must have excellent interpersonal skills and the ability to work well under pressure.
  • Requires strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration.

 If interested, please email your resume as a Word attachment to us, reference 3950.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.