GRA CMC Lead
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.
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.
About Sanofi
We’re 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 improvepeople’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.
About You
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.
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 is now open for applications.
AI Usage
"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyzedata and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identifypatterns, 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 regardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,Data Subject Rights Webform. TheData Subject Rights Webform can also be used torequest access or correction of your personal information and file a complaint.
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.
#GD-SP
#LI-SP
#LI-Onsite
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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
North America Applicants Only
The salary range for this position is:
108,900.00 - 157,300.00Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA) LINK OR (US) LINK.
La fourchette salariale pour ce poste est la suivante:
108,900.00 - 157,300.00La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien