Are you a Regulatory Affairs professional ready to navigate the dynamic landscape of pharmaceutical compliance? Coral Drugs Pvt. Ltd. invites you to join our team as a Regulatory Affairs Officer, where your expertise will play a pivotal role in ensuring adherence to regulatory standards and contributing to the success of our innovative pharmaceutical solutions.
As a leading pharmaceutical player, Coral Drugs Pvt. Ltd. is dedicated to delivering high-quality, life-changing medicines to the global market. Joining our Regulatory Affairs team means being at the forefront of ensuring that our products meet the highest regulatory standards. You’ll have the opportunity to contribute to the regulatory strategy, compliance, and approvals for our diverse portfolio of pharmaceuticals.
Job Title: Regulatory Affair Officer
Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.
1. Submission of technical data package and Applicant’s Part for semi-regulated markets.
2. Submission of response to deficiencies received from authorities and customers.
3. Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments for post approval changes for US, EU, Canada, CEP and other markets.
4. Use of eCTD software’s and submission gateways like ESG & CESP.
5. Providing regulatory inputs in early development phase of APIs.
6. Review of change controls and technical data required for DMF submissions.
7. Collection and review of data (AMV, process Validation stability etc.) required for compilation DMF.
8. Preparation of LOA and commitment and data management.
9. Submission of change notification for customer.
10. Tracking of changes in pharmacopoeia, regulatory guidance, current trends / regulatory expectations and identification of gaps.
11. Maintenance of database for regulatory submissions including customer notifications.
12. Well versed with current regulatory guidelines.
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