- 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.
To apply for this job please visit www.brunel.net.