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Jobs in Kuwait - career in Kuwait - vacancies in Kuwait-Drug and Regulatory Affairs Manager - MINDFREE Consulting-Jobs in Kuwait - career in Kuwait - vacancies in Kuwait
- University Degree in Science (Pharmacy, Medical, Chemistry)
- 2 to 3 years of Experience
- Fluent in English and Arabic
- Interactive and efficient coordination of the preparation and submission of the new registration files and Life cycle maintenance files to ensure a timely Launch of new products, and smooth supply continuity of the registered products
- Full regulatory support to the Commercial team, Supply Chain, Marketing Department and Compliance Committee to meet the TGT of OGS and Yemen markets
- 2 to 3 years’ experience in the regulatory field (new submission/ maintenance activity/ tender/ pricing) in the Gulf countries
• Active coordination of the preparation and submission of the registration files in a timely manner, in line with the registration planning and ME management instruction
• Review and compile the M1 in cooperation with the RCC department and the local distributors to fulfil the local requirements and ensure smooth and rapid submission of the files
• Prepare, review and release the artworks in coordination with the countries and the manufacturing site
- Review and Validation of the promotional material and regulatory support for the compliance committee
- Co-ordinate and respond to requests by the authorities during the evaluation process, and check the correct handling of deficiency letters within a specific timeframe ( 15 to 45 days Max)
- Follow up the maintenance of the registered products (Renewal/variation) in coordination with the LCM (Life cycle maintenance) department and the supply chain department in order to ensure smooth supply and stock management
- Complete and regular archiving the registration files and related documents
- Close follow up and monitoring of the regulatory activity with the local distributors ( Bi-weekly / or monthly meeting)
- Monthly reporting of the activity ,regular and accurate updating of the tracking tools
- Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued from the MOH, and immediate implementation within the company
- Improve and encourage the compliance practices related to the DRA activity and the business.
- Regulatory Support for the local business development activity: Local packaging/ licensing/local manufacturing
- Regulatory support for the tender business
- KPIS’s will be measured according to:
Number of submissions versus TGT
Managed stock out situations due to DRA issues
No expired registrations
Alignment level with Global RCC
Job Details
| Posted Date: |
2019-02-18 |
| Job Location: |
Al Kuwait, Kuwait |
| Job Role: |
Research and Development |
| Company Industry: |
Pharmaceutical |
Preferred Candidate
| Career Level: |
Mid Career |
| Degree: |
Bachelor's degree |
Jobs in Kuwait - career in Kuwait - vacancies in Kuwait-Drug and Regulatory Affairs Manager - MINDFREE Consulting-Jobs in Kuwait - career in Kuwait - vacancies in Kuwait
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