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.