Regulatory Affairs Specialist

8 hours ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time
Key Accountabilities/Responsibilities:
  • Develop and implement regulatory strategies to ensure timely and compliant product approvals.
  • Lead the preparation, filing, and approval of regulatory submissions to meet business objectives.
  • Ensure compliance with applicable regulations, guidelines, and industry standards.
  • Build and maintain relationships with regulatory agencies to improve submission approval times and achieve competitive labeling.
  • Collaborate with cross-functional teams to achieve regulatory objectives.
  • Identify and respond to regulatory issues related to assigned projects and products.
  • Stay up-to-date with Canadian regulations, guidelines, and policies affecting GSK's regulatory activities.
  • Mentor junior staff to develop their regulatory expertise.
Qualifications Required:
  • Bachelor's degree in a life science or relevant scientific field.
  • Extensive experience in Canadian regulatory affairs, 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.
  • 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 communication, influencing, and relationship management skills.
  • Strong project management skills and ability to act with integrity.
  • Ability to provide and receive feedback, raise issues, and share experiences and lessons learned.
  • Proactive and committed to continuous learning and development.
  • Strong team collaboration and quality mindset.
  • Strong computer literacy and skills in Microsoft Office applications.
Preferred Qualifications:
  • Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

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