hireejobsgulf
Register for Job

Regulatory Affairs Associate

1.00 to 10.00 Years   Al Kuwait, Kuwait   07 May, 2021
Al Mojil Drugs Company
1 Jobs Openings
Job LocationAl Kuwait, Kuwait
EducationBachelor's degree / higher diploma
SalaryNot Mentioned
IndustryMedical & Healthcare Equipment
Functional AreaNot Mentioned

Job Description

Job Purpose 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 target of Kuwait and Bahrain markets.Major Accountabilities

  • 1 to 2 years? experience in the regulatory field (new submission/ maintenance activity/ tender/ pricing) in Gulf.
  • Review and compile Module 1 of the registration dossier in cooperation with the department head, the Regulatory Competence Centers (RCC) department and the local distributors to fulfil the local requirements and ensure smooth and rapid submission of the files, in a timely manner, in line with the registration planning cascaded by the department head.
  • Prepare, review and release the artworks in coordination with the countries and the manufacturing site.
  • Communicate the deficiency letters raised by the Health Authorities to the department head and RCC during evaluation within a specific timeframe.
  • Ensure that launch pre-requisites in terms of MA approval, SKU creation, artworks and analysis requirements, as applicable per local regulations, are fulfilled timely according to agreed launch dates.
  • Follow-up the maintenance of the registered products (Renewal/variation) in coordination with LCM (Life Cycle Maintenance) department and the supply chain department in order to ensure smooth supply and stock management.
  • Ensures timely submission of PSUR (Periodic Safety update report), RMP (Risk Management Plan) and DHCP letters cascaded by the Drug Safety Department (whenever applicable).
  • Complete and regular archiving of the registration files, Marketing Authorizations, variations and renewal certificates and related documents.
  • Monthly reporting of the activity, regular and accurate updating of the tracking tools.
  • Close follow-up and update the department head with the latest circulars and guidelines issued from the authorities.
  • Review and Validation of the promotional material and regulatory support for the compliance committee.
  • Escalate to department head any potential delay of on-going regulatory activities, which affect the department KPIs and/or supply continuity or any deviation from regulatory processes or foreseen price erosion.
  • Regulatory support for the tender business and the local packaging project where applicable.

Keyskills :

APPLY NOW

Related Jobs

© 2023 HireeJobsGulf All Rights Reserved