Associate Director, Manager Regulatory Affairs Compliance

4 weeks ago

Old Toronto, Canada Natural Factors Full time
p>Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs to be located in Toronto, Ontario, under a flexible working model (at least 3 days in office).

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. p>

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson. p>

We know that the success of our business depends on how well we understand and meet the diverse needs of the communities we serve. This is why we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued, and our people can reach their potential.

  • Lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.
  • Support the building of a Regulatory Affairs talent pipeline through the selection and development of regulatory professionals.
  • Conduct analysis and risk assessment of pipeline projects, develop successful regulatory strategies to meet business results.
  • 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, and maintain the life cycle of currently marketed products.
  • Manage the preparation and review of responses to Health Canada queries in a timely manner.
  • Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labeling, and implementation of local regulatory strategies.
  • Collaborate with global regulatory teams and the Global Regulatory Affairs function/teams to facilitate regulatory activities.
  • Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities.
  • Handle emerging issues and associated risk communications to stakeholders.
  • Provide regulatory guidance to internal collaborators on messaging, promotional material review, and PAAB responses.
  • Monitor the regulatory environment, interpret changes, analyze gaps, and conduct impact assessments.
  • Shape Health Canada policies to pave a favorable regulatory environment for pipeline products.

Experience and Skills:

Required:

  • 5-8 years of Regulatory Affairs pharmaceutical or related experience.
  • Solid understanding of Canadian drug laws, regulations, guidelines and policies.
  • Understanding of the application of laws, regulations, guidances and policies to specific projects.
  • Ability to interpret and understand Regulations in the context of the scientific and commercial environment.
  • Ability to interpret, summarize and communicate clinical data.
  • Well-developed project management skills and ability to manage multiple priorities.

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