Senior Director, Global Regulatory Strategy, Therapeutic Area Lead

About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare disease space. This role will provide strategic regulatory input to regulatory product teams and cross-functional development teams responsible for global programs.  Ensure effective communication and constructive working relationships within the Biogen matrix. Collaborate closely and set appropriate expectations with Biogen business partners as well as representatives of regulatory authorities / agencies and have budget/personnel resource oversight. What you’ll do:

• Ensure optimal regulatory leadership and serve as a strategic advisory partner for assigned programs, US business, Above-Country Europe regional businesses and FDA/EMA Regulatory Agencies.
• Accountable for a seamless Global Regulatory strategy for assigned programs by collaborating closely with Global and Regional (including Japan and China) Regulatory & Business leaders
• Promote aligned, innovative Global Regulatory solutions drawing upon Global and regional regulatory expertise and strategies
• Identify the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.