Remote Combination Products Regulatory Affairs Manager

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Fri, Feb 19, 2021

This job expires in: 21 days

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters

Job Summary

A biopharmaceutical company has a current position open for a Remote Combination Products Regulatory Affairs Manager.

Core Responsibilities of this position include:

  • Present all information (regulatory and scientific) effectively, both orally and in writing
  • Create all submission documentation for a project with a large portfolio of products
  • Anticipate the impact of potential team decisions on the regulatory strategy, timelines & project goals

Position Requirements Include:

  • Bachelor’s degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject; is required
  • 5-8 years of experience in regulatory affairs in Medical Devices or Combination Products
  • Candidate must understand the intent of the regulations to wisely navigate the discrepancies that exist in the application of each set of regulations
  • Master’s degree is preferred. A Ph.D. is highly preferred
  • Previous experience with combination product regulatory strategy and/or execution is beneficial

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