Sanofi Group Deputy Director Regulatory Affairs in Swiftwater, Pennsylvania

Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against over 20 infectious diseases.

This position is within the Regulatory Affairs North American Business Unit.

Regulatory knowledge and expertise in clinical vaccine product development is the primary skillset required for this position. Involvement in all aspects of the clinical development process (Exploratory, Pre-Clinical, IND Application, Phase 1, Phase 2, Phase 3 and Licensure), participation in multiple project teams, development of regulatory strategy and discussions with the applicable Health Authorities are key expectations and requirements of the position. In depth knowledge and understanding of applicable North American regulations/guidelines is also required.

The individual may also be asked to organize and function as the lead contact with regulatory agencies or third parties and is responsible for the notification and inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed.

Perform any other business need identified by their direct line Manager.

Qualifications

BA/BS required. MS in Biology, Life Science or related field of study preferred.

2-5 years of applicable clinical development regulatory affairs required. Knowledge regarding submission of clinical trial applications and an understanding of both the IND and BLA processes for biologics is required. Demonstrated knowledge in microbiology, immunology, virology or bacteriology preferred. Experience working on project teams preferred.

Candidate should be a self-driven individual with skills in organization, building working relationships and communication.

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