Remote Regulatory Affairs Rx Manager

Job is Expired

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Sat, Feb 06, 2021

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A healthcare products company has an open position for a Remote Regulatory Affairs Rx Manager.

Core Responsibilities Include:

  • Independently setting regulatory strategy for complex generic product development programs
  • Assessing impact of new FDA-related regulations and guidance documents
  • Working with Project Managers to adjust regulatory submission timelines to support the business

Must meet the following requirements for consideration:

  • A minimum of 8 years of experience in the pharmaceutical industry and 6 years of hands-on experience in Regulatory Affairs
  • Bachelor degree in a healthcare-related science (e.g. biochemistry, chemistry, pharmacy, pharmacology)
  • Working knowledge of regulatory requirements and first-hand experience with US regulatory submissions
  • Prior experience preparing FDA controlled correspondence, briefing packages and conducting meetings with the Agency
  • Proven ability to write effective responses to FDA application review questions that minimize the number of review cycles
  • Knowledge in regulatory science and ANDA data requirements of all phases of product development

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