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Regulatory Affairs Director

2 months ago

Toronto, Ontario, Canada J&J Family of Companies Full time
Job Description

Johnson & Johnson Innovative Medicine is seeking an Associate Director, Regulatory Affairs to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).

We believe health is everything, and 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.

As a member of the J&J Family of Companies, we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued and our people can reach their potential.

Key Responsibilities
  • Support regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations, as well as corporate policies and procedures.
  • 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 and maintain the life cycle of currently marketed products.
  • Manage the preparation and review of responses to Health Canada queries (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) 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 (e.g. new safety or quality finding) 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 Regulatory Affairs pharmaceutical or related experience is required.
  • 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 is required.
  • Understanding of the application of laws, regulations, guidances, and policies to specific projects is required.
  • Ability to interpret and understand Regulations in the context of the scientific and commercial environment is required.
  • Strong scientific writing skills are required.
  • Ability to interpret and summarize clinical data is required.
  • Well-developed project management skills and ability to manage multiple priorities is required.

We are an equal opportunities employer and welcome applications from diverse candidates. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.