Regulatory Affairs Strategic Director

5 days ago

Toronto, Ontario, Canada Johnson & Johnson Full time

Johnson & Johnson is a global healthcare leader, dedicated to delivering innovative medical solutions that address complex health challenges. We believe in the power of teamwork and collaboration, and we're committed to fostering a diverse and inclusive work environment where everyone has the opportunity to grow and thrive.

About the Role

We're seeking an experienced Regulatory Affairs Strategic Director to join our team in Toronto, Ontario. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with Canadian drug laws and regulations, as well as corporate policies and procedures.

The ideal candidate will have a strong working knowledge of the drug development process, a solid understanding of Canadian drug laws, regulations, guidelines, and policies, and the ability to interpret and understand regulations in the context of the scientific and commercial environment.

Key Responsibilities
  1. Lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.
  2. Support the building of a Regulatory Affairs talent pipeline through the selection and development of regulatory professionals.
  3. Conduct analysis and risk assessment of pipeline projects, develop successful regulatory strategies to meet business results.
  4. Lead the preparation and compilation of regulatory submissions, including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Notifiable Changes (NCs), and ad hoc reports to Health Canada.
  5. Manage the preparation and review of responses to Health Canada queries in a timely manner.
  6. Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labeling, and implementation of local regulatory strategies.
  7. Collaborate with global regulatory teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities.
Requirements
  • Minimum B.Sc. in Biological or related sciences; advanced degree preferred.
  • 5-8 years of Regulatory Affairs pharmaceutical or related experience.
  • Strong negotiation and influencing skills.
  • Well-defined problem-solving and analytical skills.
  • Excellent communication (oral and written) and customer service skills.

We offer a competitive salary range of $140,000 - $180,000 per annum, depending on experience, as well as a comprehensive benefits package, opportunities for professional growth and development, and a dynamic work environment that values diversity, equity, and inclusion. If you are passionate about regulatory affairs and want to make a meaningful contribution to the health and wellbeing of people around the world, we encourage you to apply for this exciting opportunity.

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