Senior Associate Regulatory and Business Continuity
About this role
Senior Associate Regulatory and Business Continuity
Job Summary
You will work closely with the Regulatory & Business Continuity Sr. Manager to ensure the compliance and completion of assigned activities and provide regulatory assessment in compliance with US FDA regulations, guidance, and applicable industry guidelines to internal and external stakeholders, and ensure the implementation. This position will be located at Princeton, NJ.
Area Of Responsibility
- Prepares the submissions (ANDAs, amendments, supplements, annual reports) to support commercial business and to be-in compliance to FDA regulations.
- Coordinate with all stake holders in preparing for deficiency responses for the submissions (ANDAs / supplements)
- Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA
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