Sanofi Group Labeling Strategist, Global Regulatory Affairs - Vaccine in Swiftwater, Pennsylvania
The purpose of the position is to prepare Corporate, US and EU labeling (prescribing information, patient information and other labeling components) documents for developmental, Life Cycle Management and marketed products to obtain company and/or agency approval.
Development or updates of labeling is based on CMC or clinical data from internal or external source such as literature or other information relevant to the product or product class. The position includes the coordination of labeling review and approval throughout the company; preparation of labeling components for submission to regulatory agencies; participation in labeling negotiations with agencies resulting in product approvals or labeling updates; and release of labeling for use throughout the company; review of local labeling and participation with affiliates in agency replies for local issues and to assure compliance with corporate labeling. The position also includes mentoring of junior employees in labeling processes and procedures.
Detailed knowledge of US, EU and other local regulatory requirements pertaining to labeling, marketing authorization filings for new vaccines or updates to existing vaccines;
Knowledge of vaccine development and life cycle
Knowledge of labeling requirements in all regions;
Strong organizational skills and ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
Education and Experience:
Bachelor's degree in scientific or medically-related field. Master's degree in scientific or medically-related field preferred.
Minimum of five years experience in the pharmaceutical industry, including regulatory experience and 8 or more years in work experience.
Sanofi 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.