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
