Job Description

Reference No. R2828146
Position Title: Specialist, Regulatory Chemistry, Manufacturing and Controls (CMC)
Department: Regulatory CMC
Location: Toronto, Canada
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.
Accountable for maintaining high quality local Regulatory CMC documents for marketed products.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Responsible for timely initiation of compliance review of open change controls that are pending local Regulatory CMC action.
Perform license conformance gap analyses and complete mitigation actions as applicable.
Maintain internal templates and style guides for local Regulatory CMC documents, taking initiative for continuous improvement and simplification.
Support CMC aspects of the submission dossier and local regulatory documents, for all levels of post-Notice of Compliance quality changes submissions, Yearly Biologic Product Reports, and response to Health Canada questions, where applicable.
Provide Regulatory CMC review and input for compliance with the Canadian Environmental Protection Act.
Provide Regulatory CMC input in response to tenders or Health Care Professional inquiries, where applicable.
Participate in Sanofi GRA teams and tasks forces.
Provide comments on draft Health Canada (for prescription drugs, biological drugs and medical devices) and ICH policies and guidance's.
Maintain sound knowledge of Canadian and foreign regulations and policies/guidelines and keep abreast of scientific developments in key CMC areas.
Maintenance of internal databases in timely manner.
About You

• BSc. (required), or a degree in Pharmacy or a health?related specialty with 1 year of experience in Regulatory Affairs CMC.

Certificate, or equivalent, for completion of post-graduate program in Canadian Regulatory Affairs (required)
Working knowledge of CMC regulations and guidelines from Health Canada and ICH; awareness of other regional regulatory environment (e.g., FDA, EMA). * Solid understanding of manufacturing processes and characteristics of various drug dosage forms; ability to interpret potential risk to product quality.

• Attention to details and receptive to feedback for continuous development.
• 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
• Proficiency with Microsoft Office Suite and digital acumen are required
• Veeva RIM 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
This position is for a new vacant role that we are actively hiring for.?
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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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But 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. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our and check out our Diversity Equity and Inclusion actions at !
North America Applicants Only
The salary range for this position is: $94,700.00 - $136,766.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .
La fourchette salariale pour ce poste est la suivante:
$94,700.00 - $136,766.66
Toute compensation sera determinee en fonction de l'experience demontree. Les employes peuvent etre admissibles a participer aux programmes d'avantages sociau de l'enterprise. Des informations supplementaires sur les avantages sont disponibles via le .

Skills Required