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Regulatory Affairs Director

2 months ago

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

We are seeking a highly skilled Regulatory Affairs Director to join our team at Johnson & Johnson. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with Canadian drug laws and regulations, as well as corporate policies and procedures.

Key Responsibilities
  • Regulatory Strategy Development: Develop and implement regulatory strategies to meet project deliverables, both as a member of a team and in leading others.
  • Regulatory Submission Preparation: 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.
  • Regulatory Compliance: Ensure compliance with Canadian drug laws and regulations, as well as corporate policies and procedures.
  • Team Leadership: Lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.
  • Regulatory Guidance: Provide regulatory guidance to internal collaborators on messaging, promotional material review, and PAAB responses.
  • Regulatory Environment Monitoring: Monitor the regulatory environment, interpret changes, analyze gaps, and conduct impact assessments.
  • Health Canada Interaction: Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labeling, and implementation of local regulatory strategies.
Qualifications
  • Education: Minimum B.Sc. in Biological or related sciences. Advanced degree preferred.
  • Experience: 5+ years Regulatory Affairs pharmaceutical or related experience is required.
  • Skills: Strong working knowledge of the drug development process, 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.
  • Leadership Skills: Well-developed project management skills, ability to manage multiple priorities, excellent communication (oral and written) and strong interpersonal skills, strong negotiation and influencing skills, and well-developed team skills.
About Johnson & Johnson

Johnson & Johnson is a global healthcare leader that is committed to helping people live healthier, more fulfilling lives. We are a company that values diversity, equity, and inclusion, and we are dedicated to creating a workplace culture that is inclusive and supportive of all employees.