Specialist, Regulatory Chemistry, Manufacturing and Controls (CMC)

BioTalent Canada; Toronto; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading biopharma company in Toronto is seeking a Specialist in Regulatory Chemistry, Manufacturing, and Controls (CMC) to maintain high-quality regulatory documents. The ideal candidate has a BSc. and experience in Regulatory Affairs CMC, along with strong knowledge of CMC regulations. This role emphasizes attention to detail and innovative thinking while working in a supportive team environment. Health and wellness benefits are included.

Benefits

Health and wellbeing benefits

Career growth opportunities

Reward package for contributions

Qualifications

• 1 year of experience in Regulatory Affairs CMC.
• Working knowledge of CMC regulations and Health Canada guidelines.
• Solid understanding of manufacturing processes.

Responsibilities

• Maintain high quality local Regulatory CMC documents.
• Perform compliance review of change controls.
• Support CMC submission dossier and local regulatory documents.

Skills

Attention to details

Knowledge of CMC regulations

English (written and spoken)

Fosters innovation

Education

BSc. or degree in Pharmacy or health-related specialty

Certificate in Canadian Regulatory Affairs

Tools

Microsoft Office Suite

Veeva RIM

Job description

Home > Job Postings > Specialist, Regulatory Chemistry, Manufacturing and Controls (CMC)

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.

Watch ‘One day at Sanofi’ and check out our Diversity Equity and Inclusion initiatives at sanofi.com