Sr. Manager, Global Labeling
About The Position
Ready to make a global impact? Join us as a Senior Manager in Global Labeling and become a key player in shaping how life-changing therapies reach patients worldwide. This is more than a role – it’s an opportunity to lead, collaborate across cultures, and grow your career while ensuring compliance and excellence in every detail. If you’re passionate about precision, innovation, and working with diverse teams to deliver results that matter, we’d love to meet you. As a Senior Manager in Global Labeling, you will play a pivotal role in ensuring regulatory compliance and excellence across our product portfolio. You’ll lead the development and maintenance of core, EU, and US labeling documents, oversee artwork delivery, and drive implementation strategies at regional and country levels. Reporting into Global Regulatory, you’ll collaborate cross-functionally to deliver high-quality labeling that supports patient safety and product success. This is an opportunity to influence global standards and make a meaningful impact on healthcare worldwide.
Requirements
- Bachelor's degree in a scientific or medically related discipline
- 5+ years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labeling
- Strong knowledge of global labeling regulations and processes
- Proficiency with EDMS and regulatory tracking systems
- Experience interpreting regulatory guidelines and policies
- Excellent organizational and prioritization skills
- Effective cross-functional and cross-cultural collaboration
- Strong written and oral communication skills
Nice To Haves
- Advanced understanding of pharmacology and drug development
Responsibilities
- Lead creation and maintenance of core, EU, and US labeling documents for approved products
- Support development of labeling for pipeline products
- Drive cross-functional labeling team discussions and secure senior management endorsement
- Propose and align labeling strategies with regulatory objectives
- Oversee distribution and tracking of Company Core Data Sheet (CDS) updates
- Deliver EU Product Information (EUPI) and US Prescribing Information (USPI) in line with regulations
- Oversee coordination of artwork and EMA linguistic reviews
- Ensure compliance with Health Authority timelines for SPL submissions and regional implementation
- Maintain labeling compliance, SOPs, and support audits
- Provide training and guidance on labeling processes and standards
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
