Regulatory Affairs Manager, Oncology

1 month ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time
Key Accountabilities/Responsibilities:
  • Develop and implement regulatory strategies to ensure timely and efficient product approvals in the Oncology therapy area.
  • Lead a portfolio of products, including the preparation, filing, and approval of regulatory submissions to meet 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:
  • Bachelor of Science in a life science or relevant scientific field (e.g., pharmacology, toxicology, chemistry).
  • 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.
  • Thorough understanding of drug development and commercialization processes.
  • Highly innovative and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval processes, and resolving issues.
  • Agile and able to effectively navigate change.
  • 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.
  • Must act with integrity and demonstrate a strong and effective risk management perspective.
  • Ability to provide and receive feedback, raise issues, share experiences, and lessons learned.
  • Proactive and seeks to constantly learn and develop, ensuring skills meet changing business needs.
  • Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles, and perspectives.
  • Strong commitment to quality mindset.
  • Strong computer literacy and computer skills, including Word, Excel, PowerPoint, and Outlook.
Preferred Qualifications:
  • Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

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