Manager, Regulatory Affairs CMC - Vaccine

Job title: Manager, Regulatory Affairs CMC - Vaccine

Location: Toronto, Ontario

About the job

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Our Team:

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Global Regulatory Chemistry Manufacturing and Controls (CMC) Team as a Manager and you’ll develop the Global Regulatory CMC strategies for development and marketed products within Global Regulatory Affairs. You’ll have direct contact/liaison with FDA/EMA for new and marketed chemical entities using your knowledge to support strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).  Join our team and your contribution will ensure the Regulatory compliance of our portfolio while providing a competitive advantage through your Regulatory innovation.

Main responsibilities:

• Interpret global regulations & appropriately apply, implement, and communicate Regulatory CMC requirements. Identify regulatory opportunity and risk. Anticipate and communicate possible regulatory paradigm shifts that impact the company

• Develop Global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, and/or vaccine products) in collaboration with other parts of GRA

• Provide Regulatory CMC leadership, guidance, and coordination to project teams in delivering specific development and marketed product objectives

• Provide Global Regulatory Assessments for Manufacturing change controls

• Manage or directly contribute to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with R&D Functions, Manufacturing & Supply Functions and GRA Regulatory Operations.  Assure that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved.  Assure that technical and regulatory CMC issues are appropriately resolved with optimal solutions

• Contribute knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized.  Monitor the review of local and international Health Authority regulations and guidelines, contribute to the commenting process and/or develop position papers.  Assure that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated

About you

Experience:

• 3 - 8+ years pharmaceutical or related experience. Specific experience with CMC regulatory is preferred

• Preparation & management of filings; ensuring thoroughness, accuracy, timeliness of CMC dossiers & responses.

• Preparation of major filing; experience responding to Health Authority comments and issues related to submissions.

• Manufacturing, QA/QC experience desirable

Soft skills:

• Experience working in a matrix environment and excellent people skills are required.

• Previous experience working in a fast-paced environment on multiple product lines

• Strong organization skills

• Concise, informative and persuasive communication skills to impact project teams and HA interactions

• Potential to be able to mentor and train staff is desirable but not essential. 

Technical skills:

• Strong Regulatory knowledge and demonstrated application of requirements

• Foundational understanding of Artificial Intelligence and impact on industry

• Strong background in drug development, manufacture, or testing

• Familiarity with combination products

• Proficient in MS Word, Excel, PowerPoint

• Demonstrated ability to work successfully on global project teams.

Education:

• B.A./B.S. degree in a scientific discipline

• Advanced degree (Masters, PhD) in a science or health field is desirable

Languages:

• Fluent in English both spoken and written

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 and at least 14 weeks’ gender-neutral parental leave.