Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.    Job #02893 About our client Our client is a top 10 pharmaceutical company that has established a reputation as one of the most desirable companies to work for in Canada. With operations around the globe and an empowering corporate culture that is focused on the professional development of its employees, this is a strong opportunity for the right candidate! Position Location Regulatory Affairs Project Manager Toronto, Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development and execution of regulatory strategies and tactics for the registration of pharmaceutical and device products and systems 2) Manage the preparation and coordination of high-quality and timely regulatory submissions 3) Handle new drug submissions, supplemental new drug submissions, clinical trial applications, notifiable changes, and medical device license applications 4) Lead, coach, and manage the Regulatory Affairs Associate 5) Identify and communicate changes in the healthcare regulatory environment as well as their potential impact relative to internal stakeholders 6) Lead cross-functional submission and negotiation teams 7) Assist the Director (as required) in the development and enhancement of procedures and processes to ensure compliance with the Food and Drugs Act, Food and Drug Regulations, and other applicable industry standards 8) Build, maintain, and manage interactions with Canadian Health authorities and other external stakeholders through effective communication 9) Partner with company Medical and Scientific Affairs, Marketing, Legal, QA, etc. for developing regulatory strategies and ensuring regulatory compliance Requirements 1) Bachelor of Science in Pharmacy, Pharmacology, Toxicology, Biological Sciences, or equivalent 2) 6+ years of experience in Canadian regulatory affairs 3) Experience in creating and managing (at least one) new drug submissions 4) In-depth knowledge of the Food and Drugs Act as well as Food and Drug Regulations 5) Knowledge of and experience in oncology 6) Experience in managing approvals from Health Canada 's Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, and the Medical Devices Bureau 7) Ability to work independently and under pressure 8) Ability to build and maintain strong working relationships with internal and external contacts 9) Superb organizational and negotiation skills 10) Ability to think strategically 11) People-management experience a plus 12) Excellent communication skills (oral and written) 13) Proficient in computers (MS Office)
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