Regulatory Affairs Executive Assistant Manager
Regulatory Affairs Executive Assistant Manager
Posted on :
20-12-2024
Employer Active
1 Vacancy
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Job Description
Job Description:
1. Ensure that a companys 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 products release.
preparation,regulatory affairs,dossier preparation,data evaluation,negotiation,regulatory requirements,regulatory compliance,life cycle management,regulatory strategy,product licensing,scientific writing
Employment Type
Full Time
Key Skills
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