Reference No. R2764421

Position Title: Project Leader, Regulatory Chemistry, Manufacturing & Controls (CMC)

Department: Regulatory CMC

Location: Toronto, Ontario

About the Job

Accountable for all Regulatory CMC activities related to marketed and development products.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Collaborate with Sanofi Global Regulatory Affairs (GRA) teams and external partners to manage regulatory strategies, filings and approvals to meet local & global objectives.

• BSc. (required), or a degree in Pharmacy or a health-related specialty
  

• 5-10 years of combined experience in the pharmaceutical industry: Production, Quality Assurance, Quality Control, Regulatory Affairs
  

• Demonstrated success in a regulatory environment (e.g., leading a major submission).
  
• Strong knowledge of CMC regulations and guidelines from Health Canada and ICH; good knowledge of other regional regulatory environment (e.g., FDA, EMA).
  
• Solid understanding of manufacturing processes and characteristics of various drug dosage forms; good knowledge of drug development phases; good knowledge of bioequivalence principles.
  
• Strong strategic and operational thinking (i.e., able to think big picture balanced with strong analytical skills).
  
• Able to manage and influence key stakeholders.
  
• Fosters innovation (i.e., embraces new insights, concepts, trends & processes).
  
• Works well independently as well as in a group environment.
  

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

• MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat
  
• Veeva Vault database familiarity is an asset
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.