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Regulatory Affairs Associate - Drug Products (USA, US)
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- Are you ready to step into a pivotal role in the world of US regulatory affairs?
- Regulatory Affairs Specialist
- Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review.
- Evaluate Guerbet 's CMC documents for compliance with FDA requirements.
- Participate in internal or external CGXP and Pharmacovigilance audits.
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