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Regulatory Affairs Specialist

2 months 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 Canada.
  • Lead the preparation, filing, and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc.) to meet business objectives.
  • Ensure compliance with applicable Health Canada, industry, and GSK codes and guidelines.
  • Build and maintain relationships with Health Canada contacts to improve submission approval times and achieve competitive labelling.
  • Collaborate with local and global functions to achieve regulatory objectives.
  • Identify and respond to issues related to assigned projects and/or products.
  • Stay up-to-date with Canadian regulations, guidelines, and policies affecting GSK's regulatory activities.
  • Mentor junior staff to develop their skills and knowledge.
Qualifications Required:
  • 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.
  • Strong understanding of drug development and commercialization processes.
  • Ability to develop effective regulatory strategies aligned with commercial objectives.
  • Excellent communication, influencing, and relationship management skills.
  • Strong project management skills and ability to work in a fast-paced environment.
  • Ability to act with integrity and demonstrate a strong risk management perspective.
  • Proactive and committed to continuous learning and development.
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. Our success depends on our people, and we want GSK to be a place where people can thrive.