Head of Regulatory Affairs, Canada

Description

Lead, shape, drive, and execute all Regulatory Affairs priorities across all product classes (class 3 and 4 medical devices, biologic products, prescription drugs, OTC drugs, NHPs and cosmetics) for the Prescription, Aesthetic and Consumer business units in Canada, in accordance with the regulations.

Key Responsibilities

• Lead regulatory strategy development and execution to enhance speed to market for new products, and ensure maintenance of existing product licenses, across the Prescription, Aesthetic and / or Consumer business units portfolio.
• Lead the preparation and review of investigational and marketed product dossiers, and ensure high quality and timely submissions to Health Canada.
• Ensure products are registered in compliance with the applicable regulations. Obtain timely approval of post-approval changes to products approved by Health Canada.
• Partner with Global Regulatory Affairs on the local parts of dossiers.
• Represents the Regulatory Affairs department on assigned project teams.
• Ensure regulatory advice and input is proactively provided to local business strategies with regards to feasibility, requirements, and timelines, taking into account local requirements and local business needs.
• Provide strategic directions to the business, accountable for delivering project goals and aligning functional strategies with business needs.
• Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate, with minimum delay.
• Team leadership. Build regulatory capabilities. Manage resources capacity / allocation for required activities.
• Ensure review and approval of labelling, promotional and non-promotional materials ensuring their compliance with applicable Health Canada regulations, code of conduct and internal guidelines. Ensures consistency and conformity to the various published guidelines and codes of practice.
• Work with Manufacturing, Quality, Medical and Global R&D personnel to enable timely assessment and approval of new products and changes to marketed products.
• Support & facilitate launch of new products by collaboration with Marketing, Supply Chain / Production, Finance, Corporate and General Management.
• Responsible for updating artwork of packaging materials in a timely manner and tracking of packaging modifications.
• Keep abreast of relevant regulatory (including Health Canada requirements), industry, legislative, political and competitor activities to define business impact and to develop appropriate regulatory strategies accordingly for Galderma’s product portfolio.
• Shape the regulatory environment in Canada, driving an agenda to create an external environment in which our portfolio can thrive. Build a network with external regulatory experts.
• Manage the archiving of in-house regulatory files, documentation and Corporate electronic databases ensuring that all files are up-to-date and compliant, and ensure easy of retrieval.
• Contribute with 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.

Skills & Qualifications

What we offer in return

Next Steps

Our people make a difference

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.