Sanofi Group Associate Director Global Labeling in Bridgewater, New Jersey

The purpose of the position is to prepare corporate, US and EU labeling (prescribing information and patient information) documents for developmental, mature and marketed products of the GEM-EP (General Medicines and Emerging Products) portfolio to obtain company and/or agency approval. Development of labeling for these products is based on study results, coordination of labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates. The position also includes subject matter expertise in specific labeling regulations (e.g., EMA or FDA labeling rules ) and review of local labeling to assure compliance with corporate labeling.

The Labeling Manager will be responsible for the labeling of a portfolio of marketed products and projects under development.

Specific requirements and responsibilities include:

  • Support cross-functional teams as a labeling expert and contribute to the definition of global regulatory strategies and to the preparation of submission dossiers or responses to Health Authorities :

  • For R&D projects (new product or association, extension of indication …), Regional LCM

  • For the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, PSUR or pediatric worksharing, PRAC questions (signal detection…)

  • Prepare corporate labeling documents (Core Data Sheet or Core Safety Information), US and EU Summary of Product Characteristics and patient leaflet for projects and marketed products within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations.This preparation requires:

  • To take into account and assess development study reports, pharmacovigilance data (post-marketing) and any other scientific reports

  • To take into account and manage regulatory requisites pertaining to labeling and implies interface with International Health Agencies.

  • Lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC…), the labeling working group is responsible for labeling proposals and the preparation of supportive documents and dossiers for labeling modifications:

  • Coordinate the presentation of these proposals to the Senior Executive Management via a Labeling Review Committee.

  • Uses expertise in specific labeling regulations (e.g., F) to be a source of information for the department when specific questions or topics arise.

  • Competences: Thorough knowledge of regulatory requirements pertaining to marketing authorization filings for updates to existing products;

  • knowledge of labeling requirements;

  • organizational and networking skills;

  • ability to coordinate discussions across all levels of the company and partnership companies to reach resolution on labeling topics.

Education

Master's, PhD, PharmD or MD degree in scientific or medically-related field . Minimum of 5 years experience in the pharmaceutical industry including regulatory affairs. ​

#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