Global Labeling Strategy Lead
2 days ago
At Takeda Pharmaceutical, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.
Job DescriptionWe are seeking an experienced Associate Director, Global Labeling Lead to join our team. This is a critical role in the development and implementation of labeling content and strategy for multiple assigned products in various stages of drug development.
The successful candidate will have 8+ years of pharmaceutical industry experience, with 6 years of labeling experience or a combination of 5+ years regulatory and/or related experience. A strong understanding of US and/or EU regulatory requirements and guidelines is essential, as well as knowledge of other relevant regional regulatory nuances and requirements.
Key responsibilities will include:
- Developing and implementing labeling strategies for assigned products
- Managing cross-functional teams to ensure timely end-to-end label creation and Health Authority submission
- Interpreting laws, regulations, and guidance documents relevant to labeling documentation
- Escalating issues to Global Labeling management and proposing risk mitigation strategies
In return for your expertise, you can expect a competitive salary of $150,000 per year, plus benefits including medical, dental, vision insurance, a 401(k) plan, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
Takeda Pharmaceutical is 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.
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