Regulatory Affairs Officer
20 hours ago
Manufacturer of Bio-Pharmaceuticals, Soft Gel Capsules & Multi-Vitamins
**REGULATORY AFFAIRS**
Job Location: Borivali West
**Experience: Min. 2 years in Pharma Formulations**
- Conduct quality assurance activities to ensure compliance with regulatory requirements.
- Manage regulatory audits by providing necessary documentation and support.
- Maintain accurate records of all regulatory interactions and correspondence.
- Ensure all regulatory submissions, reports, and records are accurate, complete, and maintained according to company and regulatory standards.
- Develop and maintain technical files, dossiers, and other regulatory documents for all products.
- Prepare and present quality and regulatory reports to management.
- Co-ordination with respective departments for Regulatory requirements such as documents (Quality Analysis report, Comparative study report, Validation protocols and Reports, New Product Documents, Samples and Reference standards etc.)
- Should have understanding of drug regulatory affairs, CTD, ACTD, CDD, eCTD formats.
Regards,
Pooja Nair
Work Location: In person
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