Sanofi Group Manager/Senior Manager U.S. Regulatory Lead in Swiftwater, Pennsylvania
This position will be based in Bridgewater, Swiftwater, or Cambridge as part of the Sanofi North American and Global Regulatory Affairs Organization and will be responsible for providing US regulatory support for marketed Sanofi Pasteur vaccines. In this capacity, the Deputy Director, Global Regulatory Affairs, will work with the Global Regulatory Lead as part of the Marketed Product-Global Regulatory Team (Regulatory CMC, Regulatory Operations, EU and other regional representative, Labeling, etc.).
Under the direction of their Manager, the Deputy Director will serve as the primary liaison with the U.S. Food and Drug Administration (FDA) on matters related to assigned products.
The Deputy Director will oversee and bear responsibility for the successful implementation of regulatory strategies for assigned products, including labeling, submission and maintenance activities related to BLA applications.
Act as a single point of regulatory contact for the team on US regulatory issues.
Work with and participate on multi-disciplinary matrixed project teams that work to project deadlines while adhering to regulatory requirements for programs and products.
Ensure development of robust regulatory strategies for marketed products and be accountable for developing and maintaining regulatory strategy documents.
Ensure appropriate communication of Health Authority documents and appropriate updating and compliance of applications.
Consults with senior management to develop and communicate regulatory strategies and opinions for products and programs.
Participate in the development, monitoring and updating of standards and processes related to drug and biologics regulations.
Provide global support for regulatory issues or related questions that may arise related to products in the portfolio.
4+ years post-marketing regulatory experience
Prior experience maintaining INDs and BLAs for vaccines
A BS in a scientific discipline. An advanced degree preferred.
Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.