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
