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About the Role
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.
Responsibilities
- Develop CMC regulatory strategies and assess associated risks for development projects and/or registered 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.
- Coordinate the submission of CMC regulatory files and contribute to the preparation and review.
- 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.
- 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.
Requirements
- 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.
Skills
- Immunoscience
- AI-powered research
- Global CMC regulatory strategy
- Variation approvals
- Health Authority interactions
- Change Control assessment
- Regulatory inspection support
Location
- Toronto, ON
Work Type
- Fixed term, 12 months
- Onsite
Experience Level
- 4+ years
Education Level
- 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.
Salary/Compensations
- 108,900.00 - 157,300.00
Benefits
- High-quality healthcare
- Prevention and wellness programs
About the Company
- Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’slives and delivering compelling growth.
- Our deep understanding of the immune system –and innovative pipeline – enables us to invent medicines and vaccines that treat and protectmillions of people around the world.
- Together, we chase the miracles of science to improve people’s lives.
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.