Regulatory Affairs Director, Canada

3 weeks ago


Vaughan, Ontario, Canada Galderma Full time

Job Summary

Galderma is seeking a highly experienced Regulatory Affairs professional to lead our Regulatory Affairs team in Canada. As Head of Regulatory Affairs, Canada, you will be responsible for developing and executing regulatory strategies to ensure compliance with Canadian laws and regulations.

Key Responsibilities

  • Lead the development and implementation of regulatory strategies to ensure compliance with Canadian laws and regulations.
  • Collaborate with cross-functional teams to ensure regulatory requirements are met for new product launches and post-approval changes.
  • Develop and maintain relationships with Health Canada and other regulatory agencies to ensure timely and effective communication.
  • Provide regulatory guidance and support to business teams to ensure compliance with regulatory requirements.
  • Manage and maintain regulatory files and documentation to ensure compliance with company policies and procedures.

Requirements

  • At least 7 years of experience in Regulatory Affairs, with a minimum of 3 years in a leadership role.
  • 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.
  • Experience with Health Canada interactions regarding new product development, leading pre-submission meetings and post-approval changes.
  • Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

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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