Executive Director of Regulatory Affairs Strategy
We are partnering with a Late Stage Oncology and Autoimmune focused biotech company.
Key Responsibilities
Define and lead global regulatory strategy for late stage programs, from End of Phase II through BLA submission, approval and launch Lead End of Phase II, Pre BLA and other key FDA meetings, and direct EMA and other health authority interactions Shape Phase III and pivotal trial design with clinical development to support registration and labeling goals Own BLA planning and execution, including submission strategy, timelines, Module 2 content oversight and responses to health authority questions Lead labeling strategy and negotiations, and partner with commercial on launch readiness, promotional review and post approval commitments Evaluate and pursue expedited pathways such as Breakthrough Therapy, Fast Track, Accelerated Approval, Priority Review and PRIME Assess regulatory risk and present strategy, scenarios and probability of success to executive leadership and the board Serve as the regulatory lead on program and filing teams, and support partners and alliances, including business development diligence Build and mentor the regulatory team as the company grows toward commercial stage
Required Qualifications
Recent, hands on Phase III and product launch experience, having led regulatory strategy for at least one product through Phase III, BLA or NDA approval and commercial launch within the last five years 15+ years of regulatory affairs experience in biotech or pharma, including senior leadership as a Global Regulatory Lead Direct ownership of a BLA or NDA submission and approval, including labeling negotiations and health authority question responses Track record leading End of Phase II, Pre BLA/NDA and Type A, B and C meetings with FDA Experience in oncology, hematology or large molecule therapeutics such as antibodies, bispecifics or other biologics Global regulatory experience, including EMA Scientific Advice and EU submissions Strong executive presence, with the ability to influence senior leadership and communicate complex regulatory risk clearly Bachelor's degree in a scientific discipline
Preferred Qualifications
PharmD, PhD or other advanced scientific degree Experience with bispecific antibodies, immune cell engagers or cell depleting therapies Experience in both oncology and autoimmune indications Accelerated Approval experience, including confirmatory trial strategy, and familiarity with Project Optimus Experience in a small to mid sized biotech making the transition from clinical stage to commercial stage People leadership experience building and managing a regulatory team