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Regulatory Affairs Coordinator Role

1 week ago

Dubai, Dubai, United Arab Emirates GlaxoSmithKline Full time

About us

We are a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines, focusing on four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.

About the role

We are seeking a highly skilled Regulatory Affairs Associate to join our team at GlaxoSmithKline (GSK). The successful candidate will have excellent knowledge of Microsoft office packages, word processing, access, and outlook applications.

Responsibilities

  • Evaluate, prepare, coordinate, and submit regulatory documents in compliance with local regulations.
  • Ensure regulatory compliance, timely submissions, and secure regulatory approval in GNE markets.
  • Manage all internal processes between GNE-RA and the central team.
  • Enable the company to achieve its objectives by obtaining marketing authorization approvals/license maintenance on time.
  • Strategic planning for life cycle maintenance.
  • Liaise with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input, and alignment.
  • Communication and maintenance of product registration to ensure alignment with all stakeholders.