Director, Regulatory Affairs
Core
Global and Regional Regulatory Leader for CNS portfolio projects, managing strategy from proof of concept through post-approval.
Role type
Senior Director, Regulatory Affairs (Individual Contributor)
Builds
Regulatory strategies, submission dossiers, and core data sheets for CNS therapies
Domain
Biopharma, Oncology, CNS, Cell & Gene Therapies
Required skills
Global regulatory strategy, FDA/ICH compliance, IND/NDA/MAA/CTD submissions, Health Authority negotiations, CMC/clinical/nonclinical review, SOP development, cross-functional leadership
Preferred skills
CNS therapeutic area expertise, post-marketing optimization, matrix organization navigation, senior management presentation
Technologies
Electronic regulatory submission systems, regulatory templates
Responsibilities
Lead global and regional regulatory activities for assigned projects; coordinate regulatory strategy development; prepare and submit regulatory documents; liaise with Health Authorities; review clinical and CMC documentation; develop regulatory functional plans and core data sheets.
Seniority
Director, strategic leadership with hands-on execution