Associate Director, Global Labeling Lead

4 weeks ago

Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time
About the Role

Takeda is seeking an experienced Associate Director, Global Labeling Lead to join our team. In this role, you will be responsible for the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development.

As a key member of our global labeling team, you will work closely with cross-functional teams to drive alignment and collaboration on labeling strategy and content. You will also interface with senior management to ensure timely and effective labeling implementation.

The ideal candidate will have a strong background in pharmaceutical labeling, with experience in developing and implementing labeling content and strategy for global products. You will possess excellent communication and project management skills, with the ability to work independently and collaboratively in a fast-paced environment.

Key Responsibilities
  • Develop and implement labeling content and strategy for multiple assigned products
  • Work closely with cross-functional teams to drive alignment and collaboration on labeling strategy and content
  • Interface with senior management to ensure timely and effective labeling implementation
  • Manage labeling cross-functional teams and coordinate the process to obtain labeling approval
  • Author and manage outgoing communications regarding significant labeling changes
Requirements
  • Bachelor's degree in a relevant field, advanced degree preferred
  • 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or combination of 5+ years regulatory and/or related experience
  • Strong knowledge of US and EU product labeling requirements, regulations, and guidelines
  • Knowledge of scientific principles and regulatory/quality systems relevant to drug development
  • Ability to create, revise, and/or update product labeling for regulatory submissions
About Takeda

Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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