FDA Relations Director Job Description

April 27, 20120 Comments

FDA Relations Director Job Profile and Description

The FDA Relations Director works in Pharmaceutical companies as well as research and development companies engaged in foods and medicines that constantly apply for FDA marketing permits and clearances. The position provides functional leadership to a team of FDA relations officers who prepare the necessary documentation, clinical trials and other tests of newly formulated drugs and processed foods in obtaining FDA clearances.

FDA Relations Director Duties and Responsibilities

  • Coordinate with the organization’s R&D team to secure FDA application for marketing clearance of newly developed pharmaceutical and food products.
  • Motivate a team of FDA relations officer to perform their duties and responsibilities in securing the necessary permits for newly development products.
  • Represent the organization with meeting with FDA officials for matters concerning clearance application and testing protocols.
  • Attend lectures and seminar sponsored by the FDA and other relevant regulatory agencies.
  • Conduct final screening interviews for applicants in the management positions of the division.

FDA Relations Director Skills and Specification

  • Should have a thorough grasp of FDA regulations and the clinical testing protocols mandated by its regulations.
  • Should have excellent organization, leaderships and managerial skills with willingness to work long hours and under pressure.
  • Should have excellent communication, social and interpersonal skills

FDA Relations Director Education and Qualification

  • A BS degree in the sciences relevant to pharmaceutical work is basic is necessary
  • A master’s degree is an advantage
  • 6-10 years of experience in the pharmaceutical industries with the last 3-5 years in government regulatory affairs is an added advantage

FDA Relations Director Job Salary

The annual salary of an FDA Relations Director working in pharmaceutical organization varies depending on the size of the organization, extent of R&D, state and holder’s qualification. Typically, the position earns between $100,000 and $130,000 per annum.

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