About this Role:

As the US Regulatory Policy Lead, you will lead and develop effective approaches to US regulatory policy activities, including setting policy agenda and priorities, generating positions, influencing plans, tracking and internal communications. You will develop effective strategies to represent Biogen in interactions with Trade Associations and FDA on advocacy issues. You will also foster relationships with key decision makers and leverage insider status to gain insight and intelligence. In this role you will facilitate the connection of internal subject matter experts on key regulatory policy issues; both reactive and proactive issues and will drive the assessment of USA regulatory policy issues as well as align with global policy priorities and issues to partner with internal stakeholders, especially Government Affairs, Patient Advocacy, and Regulatory Leads.

What You’ll Do:

·       Leads the development of USA regulatory policy priorities, generates policy positions, develops action plans, tracks each and provides internal communications. 

·       Leads assigned global regulatory policy priorities.

·       In partnership with local regulatory affairs team members, support Biogen’s interactions with FDA on advocacy issues, fostering relationships with key policy decision makers and leverage insider status to gain insight and intelligence.

·       Develop and maintain USA regulatory landscape analysis. Actively informs regulatory team on key issues, emerging regulatory and legislative changes, FDA personnel changes and procedures that may impact Biogen’s strategy and products.

·       Maintains expertise of broad regulatory knowledge and policies. Focused on USA expertise while aligning across global regulatory knowledge and policy issues.

·       Leads and develops effective approaches to regulatory intelligence to increase utilization across the organization to support the development of effective strategies and decision making.

·       Represents Biogen on key Trade Association’s committees, working groups, etc. Staff Senior Biogen TA representatives.

Who You Are:

In addition to having knowledge in Regulatory Policy and FDA law, you successfully worked in a matrix environment where you collaborated with subject matter experts. You have strong regulatory experience and strong teamwork capabilities to lead and develop effective approaches to US regulatory policy activities.

Required Skills:

·       7-10 years of experience working in Regulatory Policy either within a Regulatory Agency and/or in the Biopharmaceutical Industry.

·       Excellent working knowledge of FDA law and regulatory framework and how it applies to Biopharm product development.

·       Bachelor's degree in a field such as law, pharmacy, medicine, or science required.

·       Experience in interfacing with relevant regulatory authorities.

·       Experience and knowledge in working in partnership with Government Affairs as it relates to legislation focus policy

·       Knowledge and understanding of applicable regulations.

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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.