Director, GRA Labeling

Director, GRA Labeling, Specialty Care

The purpose of this position 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 Specialty Care Global Business Unit portfolio, 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.

Major Duties and Responsibilities

• Responsible for labeling content that supports the safe and effective use of the product that meets the company's strategic requirements. 

• Oversees and prepares updates to labeling for Sanofi products considered as Life Cycle Management (LCM) products resulting in completion of internal and external approved product labeling for LCM products, including Corporate, US and EU labeling.

• Oversees and prepares developmental labeling for new products based on study data and labeling requirements worldwide resulting in internal and health authority approved product labeling including Corporate, US and EU labeling.

• 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.

• Oversees and prepares labeling for submission to regulatory agencies resulting in submission of labeling as part of Marketing Authorization Application or updates to Marketing Authorization Applications.

• Participates in labeling negotiations with regulatory agencies resulting in approved labeling allowing marketing of the product. Oversees preparation of or prepares printing (artwork) requests for US labeling resulting in release of current labeling within the company for distribution and promotion of the products inside and outside the company.

• Reviews local labeling for compliance with corporate labeling.

• Ensure that direct reports are current in their knowledge of regulatory requirements, competitor analyses and therapeutic area.

• Leads, contributes to transversal initiatives as needed to improve processes, systems within the department.

Competencies

• Knowledge of regulatory requirements  in major markets pertaining to marketing authorization filings for new products or updates to existing products;

• expert knowledge of labeling requirements for drugs, drug-device combinations;

• proven ability to lead and develop direct reports; 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 7 years’ experience in the pharmaceutical industry including regulatory affairs and labeling, 10 or more years work experience.

• Development product labeling experience is required.

• Experience in Hematology, Oncology, Rare diseases or Immuno-inflammatory diseases preferred.

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. 

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.

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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.