Manager, Regulatory Affairs
Site Name: Canada - Ontario - Mississauga
Posted Date: May 21 2020
We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. Our consumer healthcare products have a heritage that goes back more than 160 years, producing some of the world's best-loved healthcare brands including: Sensodyne, Pronamel, Voltaren, Buckley's, Neocitran and TUMS.
•Represents RA on assigned projects, providing guidance on regulations and developing regulatory strategies. Includes review of formulas for local acceptability and claims development.
•Collaborate with Global and local stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and probability of success (POS).
•Participate in interactions (meetings, teleconferences) with regulatory authorities in order to seek guidance, expedite approval of pending applications.
•Support end-to-end regulatory compliance of products in remit.
•Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
•Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
•Review labelling and formulations for acceptability.
•Maintain high level of knowledge on the science of products within defined portfolio.
•Monitor regulatory trends that could impact portfolio.
- BA or BSc in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
- Minimum of 5 years' experience in Regulatory Affairs, 3 years in Consumer Health
- Strong negotiating skills and proven track record with regulatory bodies
- Robust regulatory strategy development and implementation
- Strong business acumen and ability to manage stakeholders
- High ability to manage multiple complex projects
Only candidates currently residing in Canada and who have the legal right to work here, will be considered
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at email@example.com
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