People at Sanofi are dedicated to making a difference in patients’ daily lives, enabling them to enjoy a healthier life.
The purpose of the position is to prepare corporate, US and EU labeling (prescribing information and patient information and other labeling components) documents for developmental, mature and LCM (life cycle management) products (prescription and non-prescription) assigned to obtain company and/or agency approval.
- Development or update of labeling for these products is based on study results, literature or other information relevant to the product or product class. Coordination of labeling review and approval throughout the E2E labeling process, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates; and release of labeling for use throughout the company.
- Coordination of review of local labeling to assure compliance with corporate labeling.
- Participation with affiliates and team for health agency replies for local issues and to assure compliance with corporate labeling.
- Can identify hurdles in implementation and raises them to be addressed.
- Must be able to work with all levels of associates and direct management within the Company (domestic/international), and demonstrate good communication, interpersonal and organizational skills.
- Thorough knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products; thorough knowledge of labeling requirements; good organizational skills and strong good ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
- Ability to lead cross-functional teams and able to negotiate, resolve conflict and build consensus.
- Creation and revision of Core, EU and US labeling document.
- Provides peer support to other LM and/or vendor oversight on routine labeling projects.
- Oversee and help train Students/trainee
- Bachelor’s degree in Life Sciences field or Pharmacy required.
- Master’s degree or PharmD preferred.
- Minimum of 5 years of work experience, with 3 in the Pharma industry with Regulatory experience preferred.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.