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Associate Director, Global Labeling Strategy

Principia Biopharma, Inc.

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Bridgewater, NJ
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Job Description

As posted by the hiring company

Job Overview:

Associate Director, GRA Labeling

The purpose of this position is to be directly responsible for the preparation of corporate, US and EU labeling (prescribing information and patient information) for Developmental and Life Cycle Management for products in therapeutic areas in Specialty Care (Neurology, Rare Diseases and Rare Blood Disorders,, Oncology and Immuno-inflammation), and to obtain internal company and/or regulatory agency approvals. 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.

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.

  • Creates, prepares updates to labeling for 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.

  • Creates, prepares developmental labeling for new products based on study reports and labeling requirements worldwide resulting in completion of internal and external 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.

  • 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.

  • 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

  • Knowledge of labeling requirements

  • Proven ability to lead and develop direct reports

  • Organizational and networking skills

  • Ability to coordinate discussions across all levels of the company to reach resolution on labeling topics.

Education and Experience

  • Master's degree or higher in scientific or medically-related field.

  • Minimum of 8 years experience in the pharmaceutical industry including regulatory affairs and labeling.

  • Development product labeling experience is preferred.

  • Experience in Neurology, Hematology, Oncology, Rare diseases or Immuno-inflammatory diseases are a plus.

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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.