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Regulatory Affairs Specialist

1.00 to 10.00 Years   Riyadh, Saudi Arabia   18 Jun, 2022
Job LocationRiyadh, Saudi Arabia
EducationBachelor's degree / higher diploma
SalaryNot Mentioned
IndustryReligious Institution & Place of Worship; Pharmaceutical Manufacturing
Functional AreaNot Mentioned

Job Description

Regulatory affairs specialist act as the link between company and regulatory authorities (SFDA), to ensure that the imported products are manufactured and distributed in compliance with appropriate governmental legislation.Job ResponsibilitiesRegulatory Affairs:

  • Acting as one of the main points of contact for SFDA and in charge for Imdad?s products.
  • Reporting the status of the products on monthly bases.
  • Ensuring that the equipment is incompliance with SFDA regulations fully.
  • Following up with logistics for importation of Imdad?s products.
  • Ensuring approval of products registration applications of equipment and consumables in KSA.
  • Ensuring the update of registrations in accordance with the relevant legislation, regulations and guidelines.
  • Preparing complete registration dossiers for all products.
  • Coordinating with suppliers in regard to equipment specifications and documentation.
  • Tracking and ensuring that the applicable fees are paid on time and all licenses are renewed in timely manner
Quality Assurance:
  • Ensure that the QMS processes are established, implemented, and maintained.
  • Report to direct manager on how well, or poorly, the QMS is performing.
  • Regular review of the QMS Objectives
  • Keeping appropriate records of any delegated duties
  • Ensuring that all the Good Distribution and storage practices are applied.

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