About This Role
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.
What You’ll Do
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
Who You Are
You are detail-oriented, highly organized, and thrive in a global, cross-functional environment. You combine regulatory expertise with strong communication skills and a passion for delivering compliant, patient-focused labeling solutions.
Required Skills
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
Preferred Skills
Advanced understanding of pharmacology and drug development
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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