Head, Regulatory Affairs, General Medicine and Vaccines Canada
About The Position
As the Head, Regulatory Affairs, General Medicine and Vaccines Canada on our GRA NA team, you’ll be fully accountable to provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle for a portfolio of development and marketed prescription products. The primary purpose of this position is to provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle for a portfolio of development and marketed prescription products, as defined by Head, Regulatory Affairs. This position may also be a designated back-up to the Head, Regulatory Affairs. 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. 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.
Requirements
- Minimum Bachelor’s degree in science or a degree in a health-related field
- 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
- 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)
- Excellent negotiation skills with demonstrated ability to manage and influence key stakeholders
- Fosters innovation (i.e., embraces new insights, concepts, trends & processes)
- English (written and spoken)
- MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat
Nice To Haves
- French is an important asset
- Veeva Vault database familiarity is an asset
Responsibilities
- Accountable for the activities of a team of professional level individuals, that cover a portfolio (as defined by Head, Regulatory Affairs) of development and marketed products –80-90% of allocated time
- Provide leadership and managerial support to submissions teams to ensure quality decisions and timely preparation of submissions to Health Canada in order to achieve the shortest time to approval and the best possible labelling.
- Ensure team maintains compliance (as per Global Regulatory Affairs performance timelines) to provision of current and accurate data in internal database systems
- Evaluate business development opportunities in order to assess optimal regulatory strategy
- Provide strategic direction and leadership in the management of clinical trial regulatory activities for defined portfolio
- Participate in Business Unit (as assigned by Head, Regulatory Affairs) cross-functional leadership team(s) to ensure strategic leadership and contribution from regulatory affairs to core business activities
- As part of RA Leadership team, assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations
- Ensure and maintain visibility and excellence of the team within business units by developing good scientific skills in the core therapeutic areas
- Maintain awareness and knowledge of new and emerging local and international (EU and US) regulatory trends as well as on basic regulatory quality Canadian requirements
- Review and provide comments on Health Canada draft guidelines and policies.
- Direct Reports: Ensure implementation of departmental vision and strategies into individual priorities and goals
- Provide constructive feedback and coaching to all direct reports on an ongoing basis to facilitate and enable the attainment of employees’ development plans
- Complete performance review activities for all direct reports as per the established corporate guidelines and practices
- Self-Development: 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
- Establish and maintain a network with the key corporate regulatory sites and business units to assure the successful execution and alignment of Canadian-specific strategies within an international corporate context
- Develop, optimize and maintain a network with key partners including the Canadian regulatory authority and key opinion leaders and seize opportunities to negotiate improved regulatory processes with the Canadian authority
- Act as Sanofi liaison to industry advocacy external groups such as BIOTECanada or Innovative Medicines Canada (IMC), as required
Benefits
- high-quality healthcare
- prevention and wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
