Preparation of dossiers for submission to various semi regulated countries (SRM) as per business requirements. This person is supposed to be well versed with regulatory guidelines in various countries including India. Coordinating with R&D, Quality and Manufacturing teams to get required documents. Also strategic planning with the IBD team to explore potential markets in the SRM territories.
MAIN DUTIES & RESPONSIBILITIES:-
1. Overall monitoring of activities related to product registration
2. Preparation of dossiers as per country specific requirements
3. Ensure timely preparation, review, verification, authentication and submission of applications and documents in compliance with regulatory requirements and statutory norms for the respective territories for registration of recombinant products in semi-regulated countries.
4. Follow up with clients across countries related to dossier submissions
5. Evaluate and review changes proposed and coordinates with Domestic and 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. Review documents and protocols or participate in investigation as and when required
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