Drug and Regulatory Affairs Manager – MINDFREE Consulting – Qatar

  • University Degree in Science (Pharmacy, Medical, Chemistry)
  • 2 to 3 years of Experience

  • Fluent in English and Country Language
  • Will be Reporting to Head of DRA
  • 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 company’s 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:
    o Number of submissions versus TGT
    o Managed stock out situations due to DRA issues
    o No expired registrations
    o Alignment level with Global RCC

Job Details

Posted Date: 2019-02-18
Job Location: Doha, Qatar
Job Role: Sales
Company Industry: Pharmaceutical

Preferred Candidate

Career Level: Mid Career
Degree: Baccalauréat

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