Job Description
REGULATORY AFFAIRS EXECUTIVE
(Nilai, Negeri Sembilan)
Job Description:
1. To prepare, coordinate documentation, compile and submit registration to National Pharmaceutical Control Bureau (NPCB) i.e. drafting Product Information/ Product Insert, conduct literature searches to support submissions, develop artworks for registration purposes, etc.
2. To ensure company's products comply with the regulations of the Pharmaceutical Bureau of Malaysia (BPFK).
3. To ensure and review the pharmaceutical product dossiers prepared is in accordance with updated Malaysian Drug Registration Guidelines before submission via online registration system (QUEST3 System).
4. To keep abreast on local and international legislations, guidelines and customer practices.
5. To keep up-to-date with company's product range.
6. To collect and collate a wide range of information via references and various media inclusive the internet.
7. To develop and write clear arguments and explanations for new product licenses and license renewals.
8. To develop and update Standard Operating Procedures for regulatory affairs systems and processes to ensure quality submissions for Malaysian Health authorities.
9. To attend to all queries pertaining to product registrations forwarded by NPCB through correspondences during registration process.
10. To prepare submissions of license variations and renewals; and adhere to strict deadlines.
11. To monitor and set timelines for license variations and renewal approvals.
12. To write clear, accessible product labels, product inserts and patient information leaflets.
13. To plan and develop product trials and interpret trial date.
14. To advise scientists and manufacturers on regulatory requirements.
15. To manage projects and team members involved with the development of new products.
16. To undertake and manage regulatory inspections.
17. To review company practices and provide advice on changes to systems.
18. To liaise with and make preparations to, regulatory authorities.
19. To negotiate with regulatory authorities for marketing authorization.
20. To specify storage, labeling and packaging requirements.
Company Description
Natural Wellness Industries Sdn Bhd is Malaysia's fastest growing nutraceutical and cosmeceutical company.
We produce a comprehensive range of natural products made from the finest organic, ethically crafted and best quality extracted medicinal ingredients to complement today's modern lifestyle. Our high regard for the well being of our clientele compels us to encourage people to use natural products rather than chemical based medications, which then leads us to our focus of making people healthy naturally.
Our formulations are created by combining science and nature, as naturally intended the medicinal herbs efficacy to be. Our rich product line is further backed by solid research and is strictly evidence based to bring you effective therapeutic dosage forms. Our products contain no artificial colors, flavors, nor preservatives.
