FDA Regulatory Affairs Manager Education and Job Requirements

FDA Regulatory Affairs Manager Requirements

The FDA Regulatory Affairs Manager usually works under an established pharmaceutical company. He/she has to shoulder a host of variegated assignments. It is of prime importance that the particular pharmaceutical products get FDA approval for being marketed and sold in the public. The FDA regulatory affairs manager guides the necessary sources to properly formulate the presentation of the effects of the drugs and arranges for the necessary lab tests so that the pharmaceutical products get the final approval from the authority. The FDA regulatory affairs manager has a team of executives who assist in structuring the manufacturing and related standards of the products.

Education Requirements:

  • The candidate should possess a high school degree in the science stream.
  • A bachelor’s degree in chemistry or biology or pharmacy with decent grades from a reputed educational institute.
  • A master’s degree in business administration from a good university would put the candidate at an advantageous position to get the job.
  • Certified training in regulatory affairs based assignments from an accredited institute is a big plus in the candidate’s profile.

Job Requirements:

  • A minimum experience at the position of a regulatory affairs executive in a well known business entity.
  • Should have an in-depth knowledge about the different regulations of the FDA.
  • Must be aware of the various types of lab testing measures and related methodologies.
  • Should possess very good skills of documentation.
  • It is necessary to have computer literacy.
  • Must be knowledgeable about the techniques of marketing in the field.

Category: Pharmaceutical Education Requirements

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  1. Pharmaceutical Education Requirements | Education Requirements | June 1, 2011

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