Regulatory Affairs (API)Jobs in SynZeal Research Private Limited - Ahmedabad, Gujarat

1. Job Title: Regulatory Affairs (API)
2. Qualification: MPharm/MSc
3. Location: SynZeal Research Private Limited - Ahmedabad, Gujarat
4. Work Experience: 2 to 5 Years

Job Description

1. Prepare and submit regulatory documents for API (Active Pharmaceutical Ingredient) as per global guidelines.
2. Compile and review DMF (Drug Master File) for USFDA, EU, and other markets.
3. Coordinate with R&D, QA, QC, and Production for regulatory documentation.
4. Handle deficiency letters, queries, and regulatory responses.
5. Ensure compliance with ICH, USFDA, EDQM, WHO guidelines.
6. Maintain product registration dossiers and variation filings.
7. Track regulatory updates and implement changes accordingly.
8. Support regulatory audits and inspections.

Take this opportunity to join SynZeal Research Private Limited - Ahmedabad, Gujarat as a Regulatory Affairs (API) in Ahmedabad, Gujarat and build a successful career in the healthcare industry. Apply today for this job opportunity and grow with a leading healthcare organization.