Regulatory Affairs Manager

2 weeks ago


Toronto, Canada Pharma People Full time

Role Overview:This position entails overseeing project management within Regulatory Affairs for both emerging and established products.Responsibilities:- Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles.- Develop and implement filing strategies, evaluating scientific and clinical data as needed.- Arrange and manage meetings with relevant regulatory authorities.- Ensure the timely preparation of regulatory submissions adhering to internal strategies and Health Authority Regulations.- Participate in cross-functional meetings, offering expertise on product strategies.- Maintain ongoing compliance for marketed products, including updates to product monographs and labels.- Review and approve promotional and non-promotional material in accordance with regulatory standards.- Manage internal databases for product portfolios.Requirements:- Change leadership skills, with the ability to adapt and prioritize effectively.- Strong strategic and analytical thinking abilities.- Capable of managing and influencing key stakeholders.- Strong submissions experience.- Openness to innovation and new processes.- Ability to work independently and collaboratively.- Bachelor's degree in a health-related field.- 5+ years of Regulatory Affairs experience, demonstrating success in regulatory environments.- Proficiency in current regulatory regulations and guidelines.- Development project management.- Cross-functional experience.Language Skills:- Proficiency in English (written and spoken). Other languages would also be a plus, though not mandatory.Computer Skills:- Proficiency in MS Outlook, PowerPoint, Word, Excel, and Adobe Acrobat.- Familiarity with Veeva Vault database is preferred.Travel:- on an occasional basis.



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