Sanofi Pasteur Inc.
Head, Regulatory Affairs, General Medicine and Vaccines Canada
Toronto, ON
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About the role
- The team serves as the direct point of contact with Health Canada, coordinating regulatory submissions, responding to authority questions, and maintaining commitments to support timely product approvals.
- The Canada Regulatory Affairs team is responsible for preparing and submitting regulatory dossiers to Health Canada to ensure regulatory compliance and obtain marketing authorizations for Sanofi's General Medicine, Specialty Care, and Vaccine portfolio products.
Responsibilities
- Ensure team maintains compliance (as per Global Regulatory Affairs performance timelines) to provision of current and accurate data in internal database systems
- Ensure and maintain visibility and excellence of the team within business units by developing good scientific skills in the core therapeutic areas
- The portfolio supports products in the General Medicine and Vaccines Business units.
Requirements
- At least 5 years of experience in regulatory affairs, as a project leader or in another related position and extensive knowledge of the regulatory environment
- Elaborate and implement a personal development plan that will allow for the attainment of personal goals and required competencies aligned to the corporate values and priorities
Skills
- Leadership and managerial skills (strong decision-making, communication, project management and risk analysis skills)
- Building effective teams
- Developed change leadership skills (i.e., ability to cope with and adapt to change, effectively prioritize, and deal with ambiguity)
- Strong strategic and operational thinking (i.e., able to think big picture balanced with strong analytical skills)
- Fosters innovation (i.e., embraces new insights, concepts, trends & processes)
- English (written and spoken)
- French is an important asset
- MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat
- Veeva Vault database familiarity is an asset
- Occasionally
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Compensation
- 158,200.00 - 208,200.00 (Includes target bonus) Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.
- 158,200.00 - 208,200.00 (Comprend le bonus cible) La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents.
Benefits
- Review and provide comments on Health Canada draft guidelines and policies.
- Ensure implementation of departmental vision and strategies into individual priorities and goals
- Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA) LINK OR (US) LINK.
Company info
- At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
- As part of RA Leadership team, assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations
Visa & Work Authorization
- ual opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity
This listing is sourced directly from Sanofi Pasteur Inc.'s careers page and normalized into a canonical job model.