Director, US Regulatory Lead Gene Therapy at Biogen in Cambridge, Massachusetts

Posted in Information Technology 2 days ago.

Type: Full Time





Job Description:

Job DescriptionAbout this role:As the US Regulatory Lead - Gene Therapy you are responsible for all aspects of the US Regulatory Strategy for the assigned development products. You are a critical member of the Regulatory Product Team providing US focused product development strategy and analyzing the impact of relevant external regulatory initiatives. You will serve as the point of contact for the Agency's interactions. You will also partner with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams representing the regulatory function on an agenda driven basis. Additionally, you will present the US regulatory position on assigned products to senior management governance committees as needed. Externally, you may participate and/or lead a variety of US focused Trade Association initiatives.What You'll Do:* Core member of the Regulatory Project team working collaboratively to weave US strategies into global strategies as they are developed.* Key contact for FDA on product(s) and with direct FDA interaction.* Ensure communications from the FDA are properly communicated to the business after assessing the feedback and outlining next steps.* Drive the US product labeling and work with the GRL to ensure core label changes are appropriately conveyed in US product labeling.* Partner with US Commercial and Ad Promo Team.* Responsible for IND and BLA submissions to FDA in partnership with Regulatory Operations.* Regulatory representative on due diligence assessments of new business opportunities as required.* Provide mentorship to junior regulatory staff.Who You Are:In addition to having exceptional relationship building with the agencies, you successfully worked in a matrix environment where you collaborated with other teams within the organization. You have strong US Regulatory experience along with strong teamwork capabilities.#LI-TD1QualificationsRequired Skills* 6+ years' experience in the pharmaceutical industry within R&D, Regulatory or a related function, with at least 5 years working in regulatory affairs.* Delivery of at least one major application (NDA or BLA) or extensive experience with late-stage development preferred.* Experience working with the FDA (ideally both with CBER and CDER)* Experience in Gene Therapy* Great leadership skills with high emotional intelligence.* Must be a great team player with strong verbal and written communication skills.Additional InformationAll your information will be kept confidential according to EEO guidelines.#LI-TD1PDN-93a1065c-2eb1-41bb-9bd2-5ebc98dd715e