Head, Regulatory Affairs, Chemistry and Manufacturing Controls; CMC), Specialty Care and Genera

Head, Regulatory Affairs, Chemistry and Manufacturing Controls (CMC), Specialty Care and General Medicine, Canada

Reference No.: R2832279

Position Title: Head, Regulatory Affairs, Chemistry and Manufacturing Controls (CMC), Specialty Care and General Medicine, Canada

Department: Regulatory Affairs

Location: Toronto, ON

About the Job: Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI‑powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Main Responsibilities:

• Accountable for a team of regulatory CMC professionals covering all development and marketed products (80‑90% of allocated time)
• Regulatory Activities and Resources (60% of allocated time):
  • Assure optimal Canadian regulatory input into the Global RA CMC working groups aligned with Canadian RA strategies
  • Provide leadership and managerial support to CMC submissions teams for timely preparation and approval
  • Plan and coordinate all submissions involving a CMC component within agreed timelines
  • Ensure content of technical documents for RA CMC submissions complies with Canadian standards
  • Assure accuracy of all CMC information in regulatory documentation
  • Assess and assure adequate reporting to authorities as per regulatory and legal requirements for CMC changes
  • Ensure compliance with CEPA and timely filing of New Substances Notification
  • Ensure the team maintains compliance to provision of current and accurate data in internal database systems
  • Provide CMC scientific advice for new business opportunities and due diligence
  • Assist Head, RA in setting strategic direction and ensuring smooth daily operations
• Regulatory Resources:
  • Support development of CMC expertise within the Regulatory Affairs team
  • Maintain awareness of new and emerging local and international regulatory trends
  • Review and provide comments on CMC‑related HC draft guidelines and policies
• Development of Human Capital (20‑30% of allocated time):
  • Ensure implementation of departmental vision and strategies into individual priorities
  • Provide constructive feedback and coaching to direct reports
  • Complete performance review activities for all direct reports
• Self‑Development:
  • Elaborate and implement a personal development plan aligned with corporate values and priorities
• Networking (10‑20% of allocated time):
  • Establish and maintain a network with key corporate regulatory sites and business units
  • Develop and maintain a network with key partners, including the Canadian regulatory authority and opinion leaders
  • Act as Sanofi liaison to industry advocacy groups such as BIOTECanada or Innovative Medicines Canada (IMC) as required

Education: Minimum Bachelor’s degree in a relevant science field (e.g., chemistry, biochemistry, pharmaceutical sciences)

Experience: At least 5 years in CMC Regulatory Affairs as a project leader; extensive knowledge of pharmaceutical R&D processes and regulatory environment

Specific Skills and/or

Competencies:

• Excellent knowledge of Regulatory Affairs, especially CMC
• Leadership and managerial skills
• Strategic agility
• Building effective teams
• Excellent communication and negotiation skills
• Strong decision‑making and project management skills
• Good risk analysis skills

Languages:

• English (written and spoken)
• French is an important asset

Computer Knowledge:

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

Travel: Occasionally

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future‑focused team.
• Discover endless opportunities to grow your talent and drive your career.
• Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution.
• Take good care of yourself and your family with a wide range of health and wellbeing benefits.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Accommodations for persons with disabilities are available upon request.

All compensation will be determined commensurately with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found here. Toute compensation sera déterminée en fonction de l’expérience démontrée…

Seniority Level: Director

Employment Type: Full‑time

Job Function: Legal

Industries: Pharmaceutical Manufacturing