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Project Leader, Regulatory Chemistry, Manufacturing & Controls (CMC)

AT Sanofi U.S.
Sanofi U.S.

Project Leader, Regulatory Chemistry, Manufacturing & Controls (CMC)

•Mississauga, Canada

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.

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  • Submission Lead for all CMC aspects of the submission dossier and local regulatory documents, for the filing of initial New Drug Submissions, all levels of post-Notice of Compliance quality changes submissions, Yearly Biologic Product Reports, and response to Health Canada questions, where applicable.
  • Contribute to the preparation of pre-submission packages.
  • Participate in Sanofi GRA teams and tasks forces.
  • Build rapport with internal stakeholders & Health Canada representatives. Liaise with Canadian Regulatory Authorities.
  • Provide comments on draft Health Canada (for prescription drugs, biological drugs and medical devices) and ICH policies and guidances.
  • Maintain sound knowledge of Canadian and foreign regulations and policies/guidelines, and keep abreast of scientific developments in key CMC areas.
  • Provide scientific and regulatory assessment for the evaluation of new business opportunities, and provide CMC advice on patents.
  • Maintenance of internal databases in timely manner as required for portfolio of products.

    • About You:

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

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

    Specific Skills and/or Competencies
    • 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.

    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

    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, 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

    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.

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    Client-provided location(s): Mississauga, ON, Canada
    Job ID: Sanofi-https://jobs.sanofi.com/en/job/mississauga/project-leader-regulatory-chemistry-manufacturing-and-controls-cmc/2649/17382633088
    Employment Type: Other

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