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Regulatory Affairs Manager, Oncology Specialist

2 months ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our Oncology team at 837 GlaxoSmithKline Inc. The successful candidate will be responsible for developing and implementing regulatory strategies to ensure compliance with applicable laws and regulations.

Key Responsibilities
  • Develop and execute regulatory strategies to achieve rapid approvals and optimal labeling for products in the Oncology therapy area.
  • Lead the preparation, filing, and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc.) to aggressive targets.
  • Ensure compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment 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.
Requirements
  • Bachelor's degree 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 the drug development and commercialization process.
  • Highly innovative and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, 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.
  • Ability to 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 that skills meet changing business needs.
  • Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset.
  • 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.