Preparation of dossiers for submission to regulated market countries (RM). This person is supposed to be well versed with regulatory guidelines in EMA and USFDA. Writing eCTD and managing the source documents for proper auditing. Coordinating with R&D, Quality and Manufacturing teams to get required documents.
MAIN DUTIES & RESPONSIBILITIES:-
1. Ensure timely preparation, review, verification, authentication and submission of applications and documents in compliance with regulatory requirements.
2. Sound knowledge of CTD dossier preparations and reviewing various sections of the dossiers
3. Follow up with regulatory agencies related to dossier submissions
4. Coordination and organizing Meetings with EMA and USFDA
5. Evaluate and review changes proposed and coordinates with International Regulatory agencies and compliance responses and requirements through change control system.
6. Participate in supporting role for audits of manufacturing facilities to ensure compliance with commitments made to Regulatory Authorities and cGMPs.
7. Discussion with R&D, coordinating with Quality department for various documents and regulatory requirements.
8. Interactions with IBD team for understanding marketing requirements
9. Overall monitoring of activities related to product registration
1. Involved in client/regulatory audits
2. Discussion with R&D team, coordinating with Quality department for various documents and regulatory requirements
3. Interactions with IBD team for understanding potential marketing opportunities