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Regulatory Affairs Specialist
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Full-time
- BioSpectra is experiencing unprecedented growth and is looking for a talented Regulatory Affairs Specialist.
- BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API’s, excipients, GMP process chemicals, and bulk GMP buffers and solutions.
- The Regulatory Affairs Specialist is directly responsible for supporting compilation, preparation, organization, and filing the submission of regulatory related documents and reports.
- Provides support documents for drug substance listing for filing to the US FDA or other global regulatory agencies as required.
- Assists in regulatory inspections including any necessary responses and CAPA plans.
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