Regulatory Affairs Executive-API Pharma (Taloja)

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.