About This Role

• The purpose of the Global Labeling group is to drive the core labeling strategy and ensure that labeling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally.
• As the Global Labeling Senior Manager, you will be responsible for supporting the development and update of core labeling documents and for overseeing implementation at a local and regional level.

 Who You Are

You will have a passion for strategic regulatory labeling and will be enthusiastic to aid in the evolution of a new labeling department in a growing company. You will have an excellent eye for detail and a demonstrated understanding of the importance of labeling governance and compliance.

What You’ll Do

Create and update core labeling documents:

• Support the timely creation/management of regulatory compliant, competitive and up to date core labeling documents including the Company Core Data Sheet (CDS), Global Patient Leaflet and Target Label Profile
• Organize and support the cross functional product Global Labeling Team to reach consensus on core labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
• Contribute to the strategy to be followed in core labeling documents, ensuring alignment with global regulatory strategies
• Oversee distribution and tracking of CDS updates, ensuring compliance is maintained within the EDMS and the Regulatory Tracking System

Oversee regional implementation:

• Oversee timely implementation of CDS updates in regional labels and monitor compliance to labeling processes
• Support Regional and Local Regulatory Leads in responding to HA queries related to labeling and collaborate with Regulatory Leads to identify and track Country Labeling Differences

 Core labeling supporting documentation:

• Oversee preparation of supporting documents for core labeling changes, in collaboration with Medical Writing, ensuring alignment to the core labeling strategy and global regulatory strategy

Maintain labeling compliance:

• Oversee and/or maintain labeling compliance for assigned products ensuring version control and tracking of CDS implementation in relevant company systems
• Create, maintain and update regulatory labeling procedures and SOPs and support relevant audits and inspections
• Maintain knowledge of current rules and regulations governing global labeling activities
• Provide training to internal stakeholders and new joiners on labeling process requirements and content standards

Required Skills

• 5 to 7 years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labeling
• Good knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development
• Proven experience with document management and regulatory tracking system

Preferred Skills   

• Bachelor's degree in a scientific or medically related discipline preferred

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.