Regulatory Affairs Specialist, Oncology

1 week ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

Key Responsibilities:

As a Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies for rapid approvals with optimal labeling for products within the Oncology therapy area. You will also be accountable for a portfolio of products, including the preparation, filing, and approval of regulatory submissions to aggressive targets.

Requirements:

  • Bachelor's degree in a life science or relevant scientific field
  • Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
  • Thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies
  • Ability to develop effective regulatory strategies aligned with commercial objectives
  • Excellent oral and written communication skills, including the ability to present information and contribute ideas in small and large groups

Why GSK?

GSK is 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. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

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