Regulatory Affairs Director, Canada
4 weeks ago
Job Summary
Galderma is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of regulatory strategies across all product classes in Canada. The ideal candidate will have a strong understanding of Canadian laws and regulations, as well as experience in team leadership and hands-on regulatory technical experience.
Key Responsibilities
- Develop and execute 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.
- Represent the Regulatory Affairs department on assigned project teams.
- Provide strategic directions to the business, accountable for delivering project goals and aligning functional strategies with business needs.
- Ensure progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate.
- Team leadership, build regulatory capabilities, and manage resources capacity/allocation for required activities.
- Ensure review and approval of labeling, promotional, and non-promotional materials ensuring compliance with applicable Health Canada regulations, code of conduct, and internal guidelines.
- 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 and 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, industry, legislative, political, and competitor activities to define business impact and 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 all files are up-to-date and compliant, and ensure easy 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.
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