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Regulatory Affairs Manager, Oncology

1 month ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time
Key Accountabilities/Responsibilities:

Develop and execute regulatory strategies to ensure timely and optimal product approvals in the Oncology therapy area.

  • Lead a portfolio of products, including the preparation, filing, and approval of regulatory submissions to aggressive targets.
  • Ensure compliance with applicable Health Canada, industry, and GSK codes and guidelines, aligning with business needs.
  • Build and maintain relationships with Health Canada contacts to improve submission approval times, achieve competitive labeling, and resolve product-related issues.
  • Communicate and influence multiple local and global functions to achieve regulatory objectives.
  • Identify and respond to issues related to assigned projects and/or products.
  • Interpret Canadian regulations, guidelines, and policies as they apply to GSK regulatory activities.
  • Mentor and train junior staff.
Qualifications Required:

A strong foundation in life sciences or a relevant scientific field, combined with extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle.

  • Bachelor's degree in life science or a relevant scientific field.
  • Thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies.
  • Thorough understanding of drug development and commercialization processes.
  • Highly innovative and creative problem solver with excellent decision-making skills.
  • Agile and able to navigate change effectively.
  • Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives.
  • Working knowledge of global regulatory agencies and their practices.
  • Excellent oral and written communication skills, including the ability to present information and contribute ideas in small and large groups.
  • Good influencing and relationship management skills.
  • Excellent negotiation skills.
  • Fully developed project management skills.
  • Strong commitment to quality mindset.
  • Strong computer literacy and computer skills, including Word, Excel, PowerPoint, and Outlook.
Why GSK?

GSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines, focusing on the science of the immune system and the use of new platform and data technologies.

We are committed to making GSK a place where people can thrive, feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves, feeling welcome, valued, and included, and where they can keep growing and look after their wellbeing.