Role & responsibilities

- Product Registration as per registration guidelines of different countries and regulatory submission. Prepare and submit variations to authorities. Follow up on submissions, timelines and approvals, with the concerned person

- Well versed with CTD formats and dossier preparation

- Ensuring samples are sent timely and coordinating with concerned person for submission, getting the receipts and follow-up on the registrations

- Checking COAs before dispatch of Commercial Orders

- Application of Product Permissions, COPPs, and coordination for addition of Recent Products in WHO GMP List

- Checking of Artwork, Leaflets of both International and Domestic Supplies

- Participate in writing and update SOP/Work Instructions and process improvements

- Travel to Manufacturing Units during the Audit by External Agencies

Preferred candidate profile

- Takes full responsibility of getting the documents organised and filing the product for registration at various countries Ministry of Health
- Willing to travel to manufacturing unit during International Audits for 5 to 7 days on comany account.

📌 Regulatory Affairs - Asst. Manager, Senior Executive, (Mumbai)
🏢 Maan Pharmaceuticals
📍 Mumbai