TITLE: Regulatory Affairs Senior Manager
LOCATION: Mississauga, Head Office - Biotech

ROLE:
•     Manage all aspects of client’s Canada’s federal Regulatory Affairs within the Inflammation therapeutic area, including preparation and management of submissions, and ongoing compliance with Canadian regulations
•     Develop Canadian regulatory strategies, tactics, and documents
•     Interact with local Business Unit and global regulatory counterparts to optimize Canadian RA strategies and labeling
•     Lead dialogue and negotiations with Health Canada to successfully resolve regulatory issues
•     Manage and deliver on overall Therapeutic Area objectives and performance targets while maintaining quality and other relevant standards
•     Work cross-functionally with other members of the client’s Canada organization as an integral part of the R&D and Commercialization teams
•     Participate as member of senior leadership team of Regulatory/Safety department
•     Contribute to global regulatory planning via liaison with international counterparts

REQUIREMENTS:
The ideal candidate will meet the following criteria:
•     Minimum B.Sc. degree in life sciences (e.g., biology, biochemistry, pharmacology, toxicology)
•     2-10 years of work experience in Regulatory Affairs
•     Experience in the Inflammation therapeutic area would be an asset
•     Thorough understanding of Canadian regulations, guidances, policies and other relevant practices in pharmaceutical and biological drug development
•     Excellent communication and presentation skills, both oral and written



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