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Regulatory Affairs Director

2 months ago

Toronto, Ontario, Canada Johnson & Johnson Full time
Job Description

Johnson & Johnson is seeking a highly skilled Regulatory Affairs Director to join our team in Toronto, Ontario. As a key member of our Regulatory Affairs department, you will be responsible for 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.
  • Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labelling, and implementation of local regulatory strategies.
  • 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, such as new safety or quality findings, 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.
  • 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.
  • Strong scientific writing skills.
  • Ability to interpret and summarize clinical data.
  • Well-developed project management skills and ability to manage multiple priorities.