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Regulatory Affairs Specialist

2 months ago

Mississauga, Ontario, Canada GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Associate/Project Leader to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will play a pivotal role in shaping the future of healthcare in Canada.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with Health Canada and industry guidelines.
  • Collaborate with cross-functional teams to prepare and submit regulatory documents, including NDSs, SNDSs, and CTAs.
  • Provide expert advice on regulatory matters, including interpretation of Canadian regulations and guidelines.
  • Communicate effectively with internal and external stakeholders to ensure regulatory needs are met.
  • Identify and respond to regulatory issues related to assigned projects.
Requirements
  • Bachelor's degree in a life science or relevant scientific field.
  • 1-3 years of experience in Canadian regulatory affairs.
  • Good working knowledge of the Canadian Food and Drug Regulations and relevant guidelines.
  • Excellent communication and negotiation skills.
  • Ability to work in a fast-paced environment and manage multiple projects simultaneously.
Why GSK?

GSK is a global biopharma company committed to delivering innovative solutions that enhance patient care and improve health outcomes. We offer a dynamic and inclusive work environment where you can thrive and grow your career.