Job Description

Reference No. R2707992

Position Title: Head, Regulatory Affairs, General Medicine & Vaccines

Department: Regulatory Affairs

Location: Mississauga, Ontario

About Sanofi Specialty Care

Sanofi\'s specialty care business unit focuses on rare diseases, rare blood disorders, neurology, immunology, and oncology. Sanofi\'s ambition is to leverage science and innovation to improve people\xe2\x80\x99s lives and be the industry leader in immunology and oncology. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities.

At Sanofi, we chase the miracles of science to improve people\xe2\x80\x99s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Position Summary:

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

Key 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 \xe2\x80\x9380-90% of allocated time.

Regulatory Activities and Resources \xe2\x80\x9360% 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. The portfolio supports products in the General Medicine and Vaccines Business units.

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.

Regulatory Resources:

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.

Development of Human Capital \xe2\x80\x93 20-30% of allocated time.

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\xe2\x80\x99 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.

Networking (10-20%).

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.

Key Requirements:

Minimum Bachelor\xe2\x80\x99s 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).

Languages:

English (written and spoken).

French is an asset.

Computer Knowledge:

MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat.

Veeva Vault database familiarity is an asset.

Travel:

Occasional

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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