- To lead and manage the Regulatory Affairs department and ensure Dossiers are delivered to customers as per the agreed requirements.   - To take a lead role in handling different regulatory requirements like EU, Australia, Africa, ROW, Japan, Latin America and Domestic markets and ensure smooth response processing, support services.  - To Develop New markets/Customers and ensure entire dossier process cycle is smoothly handled in coordination with Business Development department.  - Ensure planned Dossier submission is completed as per the Agreed plans  - Ensure Post Approval variation is handled as per EU regulatory Requirements and guidelines.   - To Coordinate with Marketing Service, Manufacturing, QA, QC and Business Development to ensure timely delivery of the dossiers and query responses of the respective markets.   - To play pivotal role of being an Interface between customers and internal departments and guide Individual members of the team to handle respective markets.  - To act as Single window for all customer Regulatory needs, queries, feedbacks, complaints  - Ensure the regulatory team is given required training on time to time basis with respect to latest updates, regulatory requirement.  Expertise :   - Should have detailed working knowledge of complex worldwide regulatory requirements and demonstrated ability to handle the global internal/external regulatory environment. This Position is identified as a Regulatory expert and will mentor teams on the latest developments in this field. This position also should possess detailed knowledge of drug development and manufacturing and supply processes.   - Should have demonstrated effective strategies to meet various regulatory/ industry bodies requirements.  Regulatory Know how : MHRA, TGA, MCC, PMDA, African Countries, ANVISA

Bangalore

Vice President/Head - Regulatory Affairs - Drug  

Vice President/Head - Regulatory Affairs - Drug   ,Job Description for Vice President/Head - Regulatory Affairs - Drug   in Strikeitrite Managment Consultants Pvt Ltd in  Bangalore for (12-18) years of experience. Apply Now!

Job Description for Vice President/Head - Regulatory Affairs - Drug   in Strikeitrite Managment Consultants Pvt Ltd in  Bangalore for (12-18) years of experience. Apply Now!