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 At least 7 years’ experience in Regulatory Affairs team leadership (=3 years) and hands-on regulatory technical experience at local affiliate level is required, in the field of class 3 and/or 4 medical devices (such as injectable dermal fillers), and preferably in prescription products (including preparation of Module 1). Additional experience in NHPs, OTCs and cosmetics is an asset. Strong knowledge of Canadian laws and regulations applicable to class 3 and/or 4 medical devices, biologic products, prescription drugs, as well as OTC drugs, NHPs and cosmetics is required. Hands-on experience reviewing advertising and promotional materials for medical devices and drugs is essential, 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 in return 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 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.