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.
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Join the Brunel Family
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.
After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.
During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.
After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth interview to review your communication and interpersonal skills.
Submission of candidates resume for client’s approval and screening.
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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