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Full Time Service Lead

2 months ago

Ontario, Canada Brunel Full time

Regulatory Affairs Team Lead (renewable contract) Remote – Ontario or Quebec


We are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable for timely, quality delivery of services as stated in Statement of Work / Job Descriptions of Managed Service Regulatory Affairs staff. The successful candidate will be responsible for performing the same duties as the Managed Services Regulatory Affairs Project Leader to ensure all compliance regulatory submissions and review of promotional and non-promotional material are completed. This is a 1-year contract position that is renewable.


Communicate with the company‘s Regulatory Affairs (RA) Head and other RA staff to ensure efficient ways of working and coordination of regulatory affairs work in scope
File regulatory submissions (from the company’s portfolios) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels
Update required to the company‘s internal systems and databases with regulatory affairs information, as per the company’s SOP’s
Communicate and work with the company‘s local (eg, Canada brand team) and global stakeholders, according to the company‘s SOPs
Prepare SNDS, PRCI and YBPR regulatory submissions to Health Canada
Review promotional and non-promotional material to ensure compliance for all products (marketed or development) from the company’s portfolios

Bachelor's degree in pharmacy or any health-related field
Minimum of 3-5 years previous experience in the preparation of regulatory submissions specific to innovative drugs
French and English (written and spoken) an asset.
Computer knowledge of Microsoft Office Suite; Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.