Assist the Regulatory Manager in ensuring compliance with worldwide pharmaceutical regulation and regulatory filings (e.g., CEP, CMC, DMF, NDA, JNDA, NDS, MAA) for the site; maintain regulatory files and databases, document regulatory activities, and participate in regulatory inspections; support GMP certificates, site master file revisions, and SOP updates.
What they are looking for
Details
- Work type
- Onsite
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