Regulatory Affairs Lead

3 weeks ago

Old Toronto, Canada Natural Factors Full time
About Johnson & Johnson

At Johnson & Johnson, we believe that health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured.

Job Description

We are seeking an Associate Director, Regulatory Affairs to be located in Toronto, Ontario, under a flexible working model (at least 3 days in office). As a key member of our team, you will lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.

Responsibilities
  • Lead Regulatory Professionals: Manage and develop a team of regulatory experts to drive business success through effective regulatory strategies.
  • Talent Pipeline Development: Identify, select, and develop talented regulatory professionals to build a robust pipeline for the future.
  • Regulatory Analysis and Strategy: Conduct thorough analysis and risk assessment of pipeline projects, developing successful regulatory strategies to meet business goals.
  • Regulatory Submissions: Lead the preparation and compilation of regulatory submissions, including New Drug Submissions, Supplemental New Drug Submissions, Notifiable Changes, and ad hoc reports, ensuring timely submission to Health Canada.
  • Response Management: Effectively manage and review responses to Health Canada queries in a timely manner.

You will work closely with cross-functional teams to ensure alignment of regulatory affairs strategy with business priorities. Your strong leadership skills and ability to interpret and understand regulations will enable you to shape Health Canada policies and pave a favorable regulatory environment for pipeline products.

Requirements
  • Experience: 5-8 years of Regulatory Affairs pharmaceutical or related experience.
  • Knowledge: Solid understanding of Canadian drug laws, regulations, guidelines, and policies.
  • Skills: Ability to interpret and understand Regulations in the context of the scientific and commercial environment, as well as project management skills and ability to manage multiple priorities.
Estimated Salary: $120,000 - $180,000 per year

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