Sanofi Group Regulatory Affairs Manager in Swiftwater, Pennsylvania

This position is responsible for managing regulatory activities for both development and licensed products in support of the North American region. The Regulatory Affairs Manager will be responsible for supporting import /export compliance and/or health authority lot release activities which includes providing guidance and subject matter expertise related to government agency standards, specifications, and policies.

Duties/Responsibilities:

  • Prepare and manage all documentation to be submitted to external regulatory authorities required for the import and export of biological materials.

  • Coordinate and manage health authority lot release activities for all FDA licensed products from the three major sites of manufacture including Swiftwater, Toronto and Marcy.

  • Acquire and maintain an in-depth knowledge of the regulatory requirements related to the North America region.

  • Actively participate in project teams, working groups, and task forces while representing Regulatory Affairs initiatives.

  • Communicate directly with health authorities and government agencies and serve as a liaison to other areas of the business.

  • Apply project management skills to appropriate activities

  • Communicate and educate members of regulatory affairs and other departments as required on new technologies and/or changing regulatory requirements

  • Other key responsibilities as assigned

  • Limited travel may be required

Education/Experience:

  • Minimum BA/BS degree in the sciences, health related field, or equivalent technical experience.

  • Demonstrated knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance

  • Working knowledge of business systems such as SAP, Trackwise, Sharepoint, etc.

  • Excellent organizational skills and ability to manage multiple priorities efficiently

  • Ability to work effectively within cross-functional teams as well as independently

  • Excellent oral and written communication skills required for coordination with internal and external business partners

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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life