Global Labeling Lead, Regulatory Affairs Expert
1 week ago
About the Company
Takeda Pharmaceutical is a patient-focused company dedicated to delivering innovative treatments and improving healthcare worldwide.
Job Summary
We are seeking an experienced Global Labeling Lead to join our team in Massachusetts. As a key member of our regulatory affairs department, you will be responsible for developing and implementing labeling strategies for multiple products across various stages of development.
Key Responsibilities
- Labeling Content Development: Create and revise product labeling content (CCDS, USPI, EU SmPC) for regulatory submissions, ensuring compliance with regulations and guidelines.
- Labeling Strategy Implementation: Develop and execute labeling implementation plans to incorporate new scientific data, safety information, and Health Authority feedback into CCDS, USPI, and EU SmPC.
- Cross-Functional Collaboration: Manage cross-functional teams, including clinical, safety, medical affairs, and commercial functions, to ensure alignment and effective communication of labeling strategies.
- Health Authority Interface: Coordinate with Health Authorities to obtain labeling approval, manage label negotiations, and provide support for partner/health authority audits and inspections.
Requirements
- Education: BSc degree preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.
- Experience: 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
- Knowledge: Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).
Compensation and Benefits
The estimated salary range for this position is $149,100 - $234,300 per year, based on location and qualifications. Takeda offers a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits.
Why Join Us?
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or any other characteristic protected by law.
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