Regulatory Affairs job vacancy at Ahmedabad in Vitalysis

POSITION: Regulatory Affairs – Executive/ Assistant Manager
Minimum 4 to 5 years experience in regulatory & Africa Market
Job Description:-
1. Ensure that a company's products comply with the regulations of the Africa regions where they want to distribute them.
2. Keep up to date with national and international legislation, guidelines and customer practices.
3. Preparation & coordination for various type of variation filing Application as per the country guidelines.
4. Dossier Preparation to Compilation entire process experience must. Dossier compilation as per CTD Country Specific.
5. Dossier Management.
6. Response to deficiency.
7. Life Cycle Management.
8. To study the country specific guidelines of various countries for preparation of Registration Dossier. Reviewing of various data/documents rcvd from plant for its transform into the country specific format for compilation of Dossier. Preparation of Summary of product Characteristics & Package insert from various reference books. Preparation of pharmacological, Toxicological and clinical data from various database.
9. Responsible and managing activities of Regulatory Affairs with emphasis on global regulatory strategy, provide regulatory advice to multidisciplinary teams on the regulatory requirements, Lead, coordinate, write, critically review and provide strategic input on regulatory filing document for pharmaceuticals, biological Nutraceuticals products.
10. Collect, collate and evaluate scientific data from a range of sources.
11. Develop and write clear arguments and explanations for new product licences and license renewals.
12. Prepare submissions of license variations and renewals to strict deadlines.
13. Monitor and set timelines for license variations and renewal approvals.
14. Write clear, accessible product labels and patient information leaflets.
15. Plan and develop product trials and interpret trial data.
16. Advise manufacturers on regulatory requirements.
17. Provide strategic advice to senior management throughout the development of a new product.
18. Undertake and manage regulatory inspections.
19. Review company practices and provide advice on changes to systems.
20. Liaise with, and make presentations to, regulatory authorities.
21. Negotiate with regulatory authorities for marketing authorization / Products Registrations.
22. Take part in the development of marketing concepts and approve packaging and advertising before a product's release.