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About the Role

Provide leadership to a team of regulatory professionals for regulatory affairs activities, including early approvals and regulatory compliance throughout the product lifecycle for development and marketed prescription products. This position may also serve as a designated back-up to the Head, Regulatory Affairs.

Responsibilities

Accountable for the activities of a team of professional level individuals, covering a portfolio of development and marketed products.
Provide leadership and managerial support to submissions teams to ensure quality decisions and timely preparation of submissions to Health Canada.
Ensure team maintains compliance with current and accurate data in internal database systems.
Evaluate business development opportunities to assess optimal regulatory strategy.
Provide strategic direction and leadership in the management of clinical trial regulatory activities for the defined portfolio.
Participate in assigned cross-functional leadership teams to ensure strategic leadership and contribution from regulatory affairs to core business activities.
Assist Head, Regulatory Affairs in setting strategic direction for the team and ensuring smooth daily operations.
Ensure and maintain visibility and excellence of the team within business units by developing good scientific skills in core therapeutic areas.
Maintain awareness and knowledge of new and emerging local and international regulatory trends, as well as basic Canadian regulatory quality requirements.
Review and provide comments on Health Canada draft guidelines and policies.
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.
Complete performance review activities for all direct reports as per corporate guidelines.
Elaborate and implement a personal development plan aligned with corporate values and priorities.
Establish and maintain a network with key corporate regulatory sites and business units.
Develop, optimize, and maintain a network with key partners including the Canadian regulatory authority and key opinion leaders.
Act as Sanofi liaison to industry advocacy external groups as required.

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.
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).
French is an important asset.
MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat.
Veeva Vault database familiarity is an asset.
Travel occasionally.

Skills

Regulatory Affairs
Project Leadership
Regulatory Compliance
Product Lifecycle Management
Team Leadership
Managerial Support
Submissions Management
Health Canada Submissions
Database Management
Business Development Evaluation
Regulatory Strategy
Clinical Trial Regulatory Activities
Cross-functional Leadership
Strategic Planning
Operational Planning
Scientific Skills
Therapeutic Area Knowledge
Regulatory Trends Analysis
Policy Review
Human Capital Development
Performance Management
Personal Development Planning
Networking
Stakeholder Management
Negotiation
Innovation
MS Outlook
MS PowerPoint
MS Word
MS Excel
Adobe Acrobat
Veeva Vault

Location

Toronto, ON

Work Type

Onsite

Experience Level

At least 5 years of experience in regulatory affairs

Education Level

Minimum Bachelor’s degree in science or a degree in a health-related field

Salary/Compensations

158,200.00 - 208,200.00 (Includes target bonus)

Benefits

High-quality healthcare
Prevention and wellness programs
Company employee benefits programs

About the Company

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
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.

Equal Opportunity

Sanofi is an equal opportunity employer committed to diversity and inclusion.
We welcome and encourage applications from all qualified applicants.
Accommodations for persons with disabilities required during the recruitment process are available upon request.
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.