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Regulatory Affairs Director

2 months ago


Toronto, Ontario, Canada J&J Family of Companies Full time
Job Title: Associate Director, Regulatory Compliance

Johnson & Johnson Innovative Medicine is seeking an Associate Director, Regulatory Compliance to join our team in Toronto, Ontario. As a key member of our Regulatory Affairs team, you will play a critical role in supporting regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations.

Key Responsibilities:
  • Develop and implement regulatory strategies to meet project deliverables, both as a member of a team and in leading others.
  • Provide guidance to local and global business partners as a subject matter authority for Regulatory Affairs.
  • 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.
  • Manage the preparation and review of responses to Health Canada queries in a timely manner.
  • Collaborate with global regulatory teams and the Global Regulatory Affairs (GRA) 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.
Requirements:
  • 5+ years of Regulatory Affairs pharmaceutical or related experience.
  • Solid understanding of Canadian drug laws, regulations, guidelines, and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions.
  • Ability to interpret and understand Regulations in the context of the scientific and commercial environment.
  • Strong scientific writing skills.
  • Ability to interpret and summarize clinical data.
  • Well-developed project management skills and ability to manage multiple priorities.
What We Offer:

Johnson & Johnson is an equal opportunities employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Apply now to join our team and contribute to the success of Johnson & Johnson Innovative Medicine.