Regulatory Affairs Director, Canada

2 weeks ago

Vaughan, Ontario, Canada Galderma Full time
Job Description

About the Role

We are seeking a highly experienced Regulatory Affairs professional to lead our Regulatory Affairs team in Canada. As a key member of our Galderma team, you will be responsible for ensuring compliance with regulatory requirements and driving business growth through effective regulatory strategies.

Key Responsibilities

  • Develop and execute regulatory strategies to enhance speed to market for new products and maintain existing product licenses across our Prescription, Aesthetic, and Consumer business units in Canada.
  • Lead the preparation and review of investigational and marketed product dossiers, ensuring high-quality and timely submissions to Health Canada.
  • Ensure products are registered in compliance with applicable regulations and obtain timely approval of post-approval changes to products approved by Health Canada.
  • Partner with Global Regulatory Affairs on local dossier preparation and review.
  • Represent the Regulatory Affairs department on assigned project teams and provide strategic direction to the business.
  • Ensure regulatory advice and input are proactively provided to local business strategies, taking into account local requirements and business needs.
  • Provide leadership and guidance to the Regulatory Affairs team, ensuring effective resource allocation and capacity management.
  • Ensure review and approval of labeling, promotional, and non-promotional materials for compliance with Health Canada regulations, code of conduct, 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 the launch of new products by collaborating 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 other regulatory agencies, as 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 a local affiliate level, with a focus on class 3 and/or 4 medical devices, biologic products, prescription drugs, OTC drugs, NHPs, and cosmetics.
  • 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.

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