Director, Regulatory Lead
Posted on Apr 5, 2021 by Biogen Idec
The US Regulatory Lead (USRL) is responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products. The USRL is a critical member of the Regulatory Product Team (RPT) providing US focused product strategy, US regulatory framework knowledge, and awareness of external regulatory initiatives. Also, serves as the single point of contact for R&D and the US business on regulatory issues for development and marketed products. The USRL partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams representing Regulatory on an agenda driven basis. The USRL will present the US regulatory position on assigned products to senior management governance committees as needed. Externally, the USRL will actively participate and/or lead a variety of US focused Trade Association initiatives, Professional Associations and other NGOs.
Core member of the RPT collaboratively working with the team to represent the US Business and weave US strategies into global strategies as they are developed.
US participant on Biogen Product Cross Functional Team as appropriate.
Key contact for FDA on product(s) and with direct FDA interaction. Ensures communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps.
Key contact for internal research, development and business partners on product(s).
Drives US product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling. Partners with US Commercial and Ad Promo Team.
Responsible for IND, NDA, and BLA submissions to FDA in partners with Regulatory Operations.
Responsible for product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling.
Regulatory representative on due diligence assessments of new business opportunities as required.
Provide mentorship to junior regulatory staff.
Will represent Biogen on industry work events and attend public meetings.
6+ years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs.
Delivery of at least one major application (NDA or BLA) or extensive experience with neurology late stage development/marketed products preferred.
Experience working with CBER/CDER.
Great leadership skills with high emotional intelligence.
Must be a great team player with strong verbal and written communication skills