Sanofi Group Director Global Regulatory Affairs CMC Biologics in Bridgewater, New Jersey

Job overview

This position will lead Global Regulatory Chemistry Manufacturing and Controls (CMC) activities for Development and Licensed biological products in accordance with the department missions: interactions and Strategic Negotiations with Agencies; Review, Approval, and Release of CMC Submissions for Fileability and Approvability; Regulatory CMC Strategy and Risk Assessments.

In addition the incumbent may lead, guide and mentor GRA CMC associates in a broad range of Regulatory CMC subjects .

The incumbent shall have strong knowledge and experience in Biologics, good negotiating and problem solving skills and ability to communicate effectively to broad sophisticated audiences both internally and externally.

The incumbent shall be able to resolve complex CMC issues by demonstrating in-depth understanding of the Bio regulations and development and industrial affairs processes.

The incumbent shall develop excellent working relationships with various internal departments, including Global Regulatory Affairs, Global CMC, Industrial Affairs, Regulatory Affiliates, as well as, external business partners.

The incumbent must demonstrate behaviors consistent with the Sanofi values as well as effective leadership with internal and outside partners.

Requirements & Qualifications

Advanced degree (MS/MA, PhD) in a science/health field (Chemistry, Pharmacy, preferably Biology).

15 years of varied and in-depth experience in most aspects of CMC including 10 years in Regulatory CMC

Biologics and a record of increasing responsibility in Regulatory CMC.

REQUIRED:

Biological/Biotec skills and experience.

A strong knowledge of development of Biologics and relevant regulations and guidelines is essential to support

registration and life-cycle management projects. Must have an awareness of key Health Authority thinking,

anticipatory foresight and be able to assume leadership of projects. Should demonstrate a high level of initiative,

independence in thinking and strategic development, and be able to communicate effectively to broad

sophisticated audiences both internally and externally.

#LI-SA

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