Global Labeling Lead
4 weeks ago
Takeda Pharmaceuticals is seeking a highly skilled Global Labeling Lead to join our team. As a key member of our regulatory affairs department, you will be responsible for the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development.
Key Responsibilities:
Develop and implement labeling content and strategy for assigned products
Manage labeling cross-functional teams and interface with senior management cross-functional teams
Ensure preparation and alignment of GLOC Chair(s) and GLOC members through respective functions
Author new/revised TLP, CCDS, USPI, and/or EU SmPC for assigned products
Requirements:
BSc degree, preferred; BA accepted
Advanced scientific degree (MSc, PhD, or PharmD) preferred
8+ years of pharmaceutical industry experience
Strong knowledge of US and EU product labeling requirements, regulations, and guidelines
About Takeda:
Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. 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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