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Head of Regulatory Affairs

1 month ago

Vaughan, Ontario, Canada Galderma Full time
Job Title: Head of Regulatory Affairs

Galderma is seeking a highly skilled and experienced Head of Regulatory Affairs to lead our regulatory strategy and ensure compliance with Canadian regulations.

Key Responsibilities:
  • Develop and execute regulatory strategies to enhance speed to market for new products and maintain existing product licenses.
  • Lead the preparation and review of investigational and marketed product dossiers for submission to Health Canada.
  • Ensure products are registered in compliance with applicable regulations and obtain timely approval of post-approval changes.
  • Partner with Global Regulatory Affairs on local dossier preparation and represent the Regulatory Affairs department on project teams.
  • Provide strategic direction to the business, accountable for delivering project goals and aligning functional strategies with business needs.
  • Ensure progress of applications and changes to registered details are communicated to local and global stakeholders.
  • Lead team leadership, build regulatory capabilities, and manage resources capacity/allocation for required activities.
  • Ensure review and approval of labeling, promotional, and non-promotional materials for compliance with Health Canada regulations and internal guidelines.
  • Collaborate with Manufacturing, Quality, Medical, and Global R&D personnel to enable timely assessment and approval of new products and changes to marketed products.
  • Support and facilitate launch of new products by collaboration with Marketing, Supply Chain/Production, Finance, Corporate, and General Management.
  • Manage the archiving of in-house regulatory files, documentation, and Corporate electronic databases ensuring compliance and ease of retrieval.
  • Contribute regulatory expertise to Health Canada audits/inspections and/or other regulatory agencies, where applicable.
  • Ensure local implementation of Global Regulatory Affairs mandatory SOPs and training.
Requirements:
  • At least 7 years' experience in Regulatory Affairs team leadership and hands-on regulatory technical experience at local affiliate level, in the field of class 3 and/or 4 medical devices, and preferably in prescription products.
  • Strong knowledge of Canadian laws and regulations applicable to class 3 and/or 4 medical devices, biologic products, prescription drugs, OTC drugs, NHPs, and cosmetics.
  • Hands-on experience reviewing advertising and promotional materials for medical devices and drugs, including experience with PAAB Code of Advertising and Ad Standards Canada.
  • Experience with Health Canada interactions regarding new product development, leading pre-submission meetings, and post-approval changes.
What We Offer:
  • A great work environment with an inspiring work ambiance.
  • Growth and development possibilities.
  • An excellent benefits program starting day one.
  • Pension program after one year of service (company contribution of up to 10%).
  • Tuition Reimbursements.
  • Service awards program.
Next Steps:
  • If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
  • The next step is a virtual conversation with the hiring manager.
  • The final step is a panel conversation with the extended team.