GRA CMC Lead

Sanofi; Toronto; On-site; CAD 109,000 - 157,000; Full time

Job summary

Sanofi in Toronto, ON is seeking a GRA CMC Lead to manage a portfolio of development and/or marketed vaccine products, defining global CMC regulatory strategy and coordinating with Health Authorities. You will collaborate with Global Regulatory Affairs, regional teams, and internal functions to prepare submissions and monitor post-approval commitments.

The role requires 4+ years in regulatory CMC, a BS/BA in science, and an advanced degree is preferred.

Qualifications

• BS/BA degree in a relevant scientific discipline required, e.g., Biology, Chemistry or Life sciences.
• Advanced degree (PharmD, PhD, MD or DVM or MSc) preferred.

Responsibilities

• Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products.
• Participate in Change Control assessment.
• Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
• Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented and risks identified.
• Develop relationships with Health Authorities and support strategic negotiations with the FDA and EMA.
• Coordinate submission of CMC regulatory files and review in collaboration with R&D and Industrial Affairs.

Skills

Regulatory strategy

Change control

Cross-functional collaboration

Health Authority liaison

Communication skills

Education

BS/BA in science

Advanced degree preferred

Job description

Position Summary

Reference No. R2867636
Position Title: GRA CMC Lead
Department: GRA CMC Vaccine Influenza & COVID
Location: Toronto, ON
Duration: Fixed term, 12 months

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. As GRA CMC Lead within our R&D team, you will be responsible for managing a portfolio of projects and/or marketed products. The GRA CMC Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing variation approvals and questions, as well as direct interactions with Health Authorities. You will work closely with Global Regulatory Affairs (GRA), Regions ("Regional GRA"), local regulatory teams, quality groups within R&D and Industrial Affairs, including in particular the RSO (Regulatory Site Officer) teams, with partners, and also with Human Resources, Legal Services, Finance, and Health Authorities. You will also be involved in internal or external programs/organizations led by Sanofi and ensure representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs.

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

• Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities.
• Participate in Change Control assessment.
• Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
• Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account.
• Ensure that requests from Health Authorities are taken into account in an effective and timely manner.
• Develop lasting relationships with the Health Authorities.
• Provide the necessary support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success.
• Draft or contribute to the drafting, preparation, review and approval of supporting documents for consultation with health authorities in order to define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs.
• Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs.
• To ensure the monitoring and management of post-approval commitments in connection with CMC activities.
• Ensure that variation files are prepared in accordance with requirements, quality standards and within the time allotted.
• Author the CMC strategy document “Global Regulatory CMC Strategy Document” in connection with the Blue Print model if applicable.
• Ensure that CMC regulatory issues are considered and resolved optimally.
• If applicable, support the regulatory inspection process.
• Contribute to Sanofi initiatives, review of local and international regulations and guidelines.
• Ensure that the requirements of the Health Authorities are taken into account and communicated.

Education

• BS/BA degree in a relevant scientific discipline required, e.g., Biology, Chemistry or Life sciences.
• Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred.

Experience

• At least 4+ years' experience in a regulatory role, highly valued if it’s within the pharmaceutical industry.
• Operational experience within an organization (medium to large) in Regulatory CMC department preferred.
• Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations.
• Ability to solve strategic technical and regulatory problems.
• Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners.

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.

Benefits

• 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.
• Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK.

AI Usage

Artificial Intelligence refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.

Equal Opportunity

Sanofi is an equal opportunity employer committed to culture, inclusion, and experience. Our goal is to attract, develop and retain highly talented employees, 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. 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.

Salary

The salary range for this position is: 108,900.00 - 157,300.00 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

La fourchette salariale pour ce poste est la suivante: 108,900.00 - 157,300.00 La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents.