Regulatory Affairs & Quality Associate / Coordinator
Stiefel Laboratories, Inc
Dubai, United Arab Emirates
منذ 21 يوم

Your Responsibilities :

Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role

  • Maintain product licenses in compliance with local regulations.
  • Registration plans for new products, major changes and life cycle management.
  • Communicate with the distributors in each of the markets to ensure optimized and compliant Registration procedures.
  • Collaborate with Medical, Marketing and Supply Chain and pro-actively ensuring Regulatory input is provided
  • Implement strategies to improve (or maintain) the legislative, regulatory and recommendation environment to better achieve business goals of GSK
  • Establish good relationships with distributers and local authorities.
  • Ensures Regulatory compliance of Product Artwork and all promotional materials addressed to his / her market to local legislation and code
  • Ensure that the business is aware of possible legislation changes that could impact GSK and advise higher management on appropriate course of action.
  • Be part of the claim validation team of the GSK in his / her region of responsibility and sign off all consumer claims.
  • Effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations / codes and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders.
  • Provide regulatory intelligence knowledge to support the development and implementation of regulatory and business.
  • Ensure proper archiving for all related document.
  • Report any risks to their line managers.
  • Basic qualifications : BSC pharmacy

    BSC pharmacy

    Minimum 4 years experience in regulatory preferred in consumer or FMCG industry

    Preferred experience in UAE

    Valid UAE MOH License is an added value

    Preferred qualifications :

    Any additional related qualification will be a plus

    Why GSK? :

    At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-

    leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy.

    To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

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