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Regulatory Affairs Director

2 months ago

Vaughan, Ontario, Canada Galderma Full time
Job Summary

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

Key Responsibilities
  • Develop and implement regulatory strategies to enhance speed to market for new products and ensure maintenance of existing product licenses.
  • 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.
  • Partner with Global Regulatory Affairs on local dossier preparation and review.
  • Represent the Regulatory Affairs department on assigned project teams.
  • Provide strategic direction to the business, accountable for delivering project goals and aligning functional strategies with business needs.
  • Communicate progress of applications and changes to registered details to local and global stakeholders.
  • Lead team members, build regulatory capabilities, and manage resource 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 collaborating with Marketing, Supply Chain/Production, Finance, Corporate, and General Management.
  • Manage archiving of in-house regulatory files, documentation, and corporate electronic databases.
  • 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.
About Us

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.