About this role
We’re hiring a Regulatory Affairs Team Lead for a pharmaceutical company for a long term contract (renewable) in Laval, QC
- Communicate with staff in efficient ways of working and coordination of regulatory affairs work in scope;
- Provide managerial support to team and direct and supervise daily work;
- File regulatory submissions to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels;
- Update required internal systems and databases with regulatory affairs information, as per SOP’s;
- Communicate and work with Sanofi local (eg, Canada brand team) and global stakeholders, according to SOPs;
- Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada;
- Interact directly with Health Canada to address questions on filed submissions to ensure approval;
- Review promotional and non-promotional material to ensure compliance for all products (marketed or development) from portfolios.
- Bachelor degree in pharmacy or any health-related field;
- Previous managerial experience;
- Minimum of 3-5 years previous experience in the preparation of regulatory submissions;
- French and English (written and spoken) ;
- Strong leadership, and decision-making skills;
- Excellent communication skills;
- Ability to build effective teams;
- Excellent understanding of the current Health Canada regulations and guidelines, including publishing eCTD requirements;
- Computer knowledge of Microsoft Office Suite; Adobe Acrobat.
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Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto
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