Associate Director, Global Labeling Lead

About This Role  

The purpose of the Global Labeling group is to drive Biogen’s regulatory labeling strategy and ensure that labeling documents are of high quality and compliant for the safe and effective use of our products globally. 

As a Global Labeling Associate Director, you would be responsible for developing the labeling strategy, leading the development and update of core, EU and US labeling documents and for overseeing implementation at a regional and local level. In this role, you may be responsible for overseeing the strategy for other products within your Therapeutic Area. 

What You’ll Do  

• Lead timely creation or management of regulatory compliant, competitive and up to date core, EU and US labeling documents throughout the product lifecycle including the Target Label Profile, Core Data Sheet, EU SmPC and USPI 

• Lead the cross functional product Labeling Team to reach consensus on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management 

• Critically assess the data and propose the labeling strategy to be followed in core, EU and US labeling documents, ensuring alignment with global, regional and local regulatory strategies 

• Oversee distribution and tracking of Core Data Sheet updates for assigned products, ensuring compliance is maintained within the Electronic Document Management System and the Regulatory Tracking System 

• Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, influence the clinical development plan

• Develop and implement strategy for global, EU and US labeling content

• Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team

• Partner with key stakeholders to ensure product labeling is the most current, accurate, relevant and competitive to inform prescribers and patients

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 a strong scientific grounding, an excellent eye for detail and a demonstrated understanding of the importance of labeling governance and compliance. 

Required Skills  

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

• 6+ years pharmaceutical/ biotechnology industry regulatory experience, including global, EU and US regulatory labeling  

• Advanced knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development 

• Experience in interpretation of global, EU and US regulations, guidelines, policy statements, etc. 

• Proven ability to successfully understand regulatory implications of product strategy<