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SANVIN group logo

Regulatory Affairs Executive-API Pharma (Taloja)

4 - 5 years

2 - 3 Lacs

Navi Mumbai, Panvel, Mumbai (All Areas)

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Drug Regulatory Affairs Regulatory Affairs USFDA Row Market API Bulk Drugs Dmf API Manufacturing RA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices and concemed departments about the same. 8. Keep up to date with a company's product range. 9. Ensure that a company's products comply with the current regulations. 10. Formulate strategy for all regulatory submissions. 11. Participate in regulatory and customer inspections, review audit reports and submit compliance report to regulatory agency. 12. Maintain approved applications in compliance with appropriate guidance 13. Identifling the tlpe of changes & submit them as per country guidelines (life cycle management). 14. Monitor progress of all registration submissions country-wise and product-wise.

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SANVIN group
SANVIN group
www.sanvin-group.com

Engineering Services

Anytown

200 Employees

18 Jobs

    Key People

  • John Doe

    CEO

  • Jane Smith

    CTO

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