Project Leader, Regulatory Chemistry, Manufacturing & Controls (CMC)
Mississauga, Canada Fixed Term Date posted Sep. 27, 2024Reference 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.
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.
#GD-SG
#LI-GZ
#LI-Onsite
Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
You have not viewed any jobs yet.
You have not saved any jobs yet.
Developing
our talent
We believe better is out there – and that extends to how we support people. Our People Strategy prioritizes inclusivity, transparency, and efficiency in talent development. It’s allowed us to chart personalized plans to keep employees and managers on the same page when it comes to training and succession planning. From upskilling to mentorship, we prepare our teams with the resources they need to pursue progress.
Find out more about this location
Experience possibility
-
When you grow, we all grow
We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.
-
Build a career with purpose
Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.
-
Bolder, better futures
Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.
-
Our locations
We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.
-
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
Sanofi at Cambridge Crossing
Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.
-
Why Sanofi
Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.
-
Our people & culture
We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.
-
Sanofi's Postdoctoral Program
Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.
-
Physician Careers at Sanofi
At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.
-
AI Centre of Excellence
The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.
-
Cambridge Crossing
We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.
-
Innovation in Action
Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.
-
Sustainable and Green
Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.
-
Sanofi’s AI Centre of Excellence in Toronto
The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.
-
Ama
Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.
-
Sanofi Canada's Philanthropic Efforts
By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.
-
Emmanuel
Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.
-
Dimitrije
Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.
-
Ziv
Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.
What could we achieve together?
Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.
What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.