Looking for a Regulatory Affairs Submission Expert! This opportunity will focus on review of the submission content and assisting by developing, documenting, and submitting/filing the appropriate supplements to the FDA.
- Supporting Regulatory CMC work, including but not limited to:
- Support Change of API suppliers and preparing CMC submission content in preparation to file supplement(s), as needed.
- Submission preparation and writing, including publishing and filing supplements
- Review existing documentation including filing, as appropriate
- Support review activities relevant testing data and report summaries.
- Draft/review supplement content, as needed
- Compile and create a submission-ready supplement (including eCTD publishing and hyperlinking)
- Provide sequence for filing and FDA's acceptance confirmation, including any other data requested.
- Thorough understanding of the drug development process for all phases of pharmaceutical development
- Strong working knowledge of US FDA regulations and ability to interact with the agency as necessary.
- Prior experience with post approval changes
- Experience with compiling or reviewing the CMC portions of supplement filings.