Regulatory Affairs Professional

2 weeks ago


Toronto, Ontario, Canada Johnson & Johnson Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Professional to manage and lead regulatory activities for drug product registration in compliance with Canadian drug laws and regulations.

The ideal candidate will have a strong working knowledge of the drug development process, clinical and therapeutic aspects of submissions, and Canadian drug laws, regulations, guidelines, and policies.

Responsibilities include developing and implementing regulatory strategic plans, leading preparation of regulatory submissions, and providing guidance to local and global business partners.

  • Develop and implement regulatory strategic plans for product registration and lifecycle management.
  • Lead the preparation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to Health Canada.
  • Collaborate with global cross-functional teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities.


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