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About Kyowa Kirin International Jobs 2022

Posted : 22-04-2022 Ends : Ongoing
Department : Kyowa Kirin International Jobs 2022
Opportunity : Kyowa Kirin International Recruiting Opportunity
Job Type : Dubai Job Vacancy 2022
Location : Jobs In Dubai
Salary/Payout : 20000.00 monthly

Kyowa Kirin International Jobs 2022Description



Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, is one that is filled with purpose.

Job Purpose

This role principally manages Kyowa Kirin regulatory aspects in the GCC countries to ensure that authorisation of products is achieved in a timely manner and post-licensing regulatory activities associated with all Kyowa Kirin’s global marketed products in the GCC are in compliance with applicable legislation and business requirements. This position supports GCC countries specifically, but not exclusively, within East, Africa region.

Key Responsibilities:

See also Core Policy 12 Regulatory Affairs for details:

  • Compliance with relevant regulatory legislation and guidelines and internal procedures in relation to gaining and maintaining marketing authorisations.
  • Defining project and product regulatory strategy in line with Kyowa Kirin’s global regulatory action plan.
  • Representation of regulatory affairs in cross-functional team meetings for defined projects, providing information, feedback and strategic advice.
  • of the regulatory activities associated with global regulatory action plan…
  • Production of all types of regulatory submissions as needed to support the Kyowa Kirin business in GCC and any other specified territories.
  • Preparation, attendance and follow up of meetings with Regulatory Agencies (e.g. requests for scientific advice on defined projects, including the generation of briefing documents and minutes).
  • Manage the provision of information requested by regulatory authorities.
  • Manage communication between Regulatory Affairs, regulatory authorities, licensing partners and affiliate regulatory affairs contracts, as required.
  • Acting on new safety information received, as appropriate, in a timely manner.
  • Maintenance of regulatory approvals including follow-up of commitments as a condition of approval, and post-approval submissions.
  • Tracking of GCC data requests and regulatory submissions, including post approval commitments/measures and other obligations.
  • Management of regulatory product information.
  • Regulatory activities are carried out in compliance with regulatory standards and company standards, such as Standard Operating Procedures (SOPs)
  • Support the continuous improvement of regulatory and cross-functional processes
  • Support the selection of junior regulatory staff, their development and training.

Position Requirements

  • Life qualification with solid experience in regulatory affairs in the pharmaceutical industry.
  • Expert knowledge of GCC pharmaceutical regulations and guidelines and/or knowledge and experience of working with partners in overseas territories.
  • Expert technical knowledge, particularly of module 3 of the Common Technical Document.
  • Expert regulatory knowledge of European and overseas markets, particularly Middle East, Africa and EU/USA
  • Can work independently and with limited supervision.

To meet the expectations of our patients and to truly deliver on our Commitment to Life, we are continually looking for people who embrace this spirit. We are committed to providing a culture that offers both inspiration and reward – in terms of compensation and in work satisfaction. And in turn, we want people who’ll bring their unique ideas and diverse approaches, while also aligning to our ultimate goal of making people smile. If this sounds like a company that aligns with your values, we’d love for you to join us in our efforts.

Kyowa Kirin International is an equal opportunities employer

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