Regulatory Affairs Officer

5 hours ago

Mumbai Maharashtra, India TheTalentforte.com Full time

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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