The purpose of this role is to oversee Labeling Strategists and be directly responsible for the preparation of corporate, US and EU labeling (prescribing information, patient information and other labeling components) for Developmental and Life Cycle Management products in Sanofi's Immunology & Inflammation and Neurology Therapeutic Areas and to obtain internal company and regulatory agency approvals. Development of labeling for these products is based on study results, safety data, literature data or other information relevant to product or product class; coordination of labeling review and approval throughout the end to end 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. The position reports to Head of Global Labeling Strategy at Sanofi.
MAJOR DUTIES AND RESPONSIBILITIES
Responsible for developing innovative labeling strategies that support the safe and effective use of the products in assigned portfolio and meet the company's strategic objectives.
Oversees and prepares developmental labeling for new products and Life-Cycle Management products based on study data , internal data, and labeling requirements worldwide resulting in internal and health authority approved product labeling including Corporate, US and EU labeling.
Oversees and prepares labeling for submission to regulatory agencies as part of Marketing Authorization Application or updates to Marketing Authorization Applications.
Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling.
Effectively contributes to labeling negotiations with regulatory agencies resulting in approved labeling allowing marketing of the product.
Ensure that labeling strategists in Therapeutic Areas are current in their knowledge of regulatory requirements, competitor analyses and therapeutic area. Coaching and mentoring direct reports for skill enhancement and professional development.
Builds and maintains relationships with key stake holders in global regulatory affairs, other R&D and commercial functions to ensure alignment on labeling strategy.
Leads, contributes to transversal initiatives as needed to improve processes, systems within the department. Brings a best practice mindset to build a best in class labeling organization
Recognized Subject Matter Expert with knowledge of labeling requirements for drugs, drug-device combinations for US, EU and other major global markets.
Expert knowledge of regulatory requirements in major markets pertaining to marketing authorization filings for new products or updates to existing products
Proven ability to lead and develop direct reports/labeling strategists in the organization
Organizational and networking skills; and ability to coordinate discussions across all levels of the company to reach resolution on labeling topics
Ability to work autonomously while providing oversight to direct reports.
EDUCATION AND EXPERIENCE
Advanced degree or higher in life science, pharmacy, medicine or medically-related field. Minimum of 10 years’ experience in the pharmaceutical industry including regulatory affairs and labeling, 12 or more years work experience.
Development product labeling experience is required.
Prior experience leading one or more therapeutic area for labeling strategy and providing oversight to direct reports required.
Experience in Immuno-inflammatory diseases and Neurology preferred
Experience managing multiple therapeutic areas 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.
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.