Symbio Generics is looking for an experienced Assistant Manager / Deputy Manager in Regulatory Affairs (API) to join our team at R&D Jigani. If you have expertise in Drug Master Files (DMF), regulatory filings, and compliance, this is a great opportunity to advance your career in the pharmaceutical industry.
Job Details
- Role: Assistant Manager / Deputy Manager – Regulatory Affairs
- Department: Regulatory Affairs (API)
- Experience: 8-12 years in Regulatory Affairs
- Qualification: M.Sc. in Chemistry (any specialization) or a related field
- Location: R&D Jigani
Job Responsibilities
- Compile Drug Master Files (DMF) / CEP dossiers and other technical documents for global markets.
- Coordinate with manufacturing sites for document submissions (USDMF, CEP, ASMF) and filings in countries like Brazil, China, Japan.
- Review technical documents to ensure compliance with regulatory requirements.
- Collaborate with R&D teams to provide necessary documentation for regulatory submissions.
- Handle and respond to global technical queries from customers.
- Review Change Control Forms (CCF) and provide regulatory assessments.
How to Apply
📧 Send your CV to: careers@symbiogenerics.com
Join us and contribute to cutting-edge developments in Regulatory Affairs for APIs!
