Global Labeling Expert
6 days ago
We are seeking an experienced Global Labeling Expert to join our team at Takeda Pharmaceutical. As a leading biopharmaceutical company, we are committed to delivering transformative therapies to patients worldwide.
Job Summary:- We are looking for a highly skilled professional to lead our labeling efforts, ensuring compliance with regulatory requirements and guidelines.
This role is responsible for developing and implementing labeling content and strategy for multiple assigned products in various stages of drug development. The successful candidate will manage Labeling Cross-Functional Teams, lead cross-functional collaboration, and align the labeling strategy and content.
Main Responsibilities:- Labeling Content Development: Author new/revised TLP, CCDS, USPI, and/or EU SmPC for assigned products, obtaining input and approval from relevant functional areas.
- Regulatory Compliance: Interpret laws, regulations, and guidance documents relevant to labeling documentation and ensure compliance with regulatory requirements.
- Cross-Functional Collaboration: Manage Labeling Cross-Functional Teams and lead cross-functional collaboration to ensure alignment of the labeling strategy and content.
The ideal candidate will have 8+ years of pharmaceutical industry experience, inclusive of 6 years of labeling experience or a combination of 5+ years regulatory and/or related experience. Advanced scientific degree (MSc, PhD, or PharmD) is preferred. Knowledge of US and/or EU regulatory requirements and guidelines is essential.
What We Offer:- A competitive salary: $120,000 - $180,000 per year.
- A comprehensive benefits package, 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.
- A diverse and inclusive work environment with equal employment opportunities to all employees and applicants.
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