Senior Director, Regulatory Affairs, CMC
Core
Provide strategic regulatory CMC leadership for major development or commercial assets, serving as a senior advisor to cross-functional teams on global regulatory submissions and agency interactions.
Role type
Senior Director, Regulatory Affairs CMC
Builds
Marketing applications, supplements, variations, and regulatory submissions for neuroscience therapeutics
Domain
Biopharmaceuticals / Neuroscience / Regulatory Affairs
Required skills
Global regulatory strategy, CMC submission preparation, agency liaison, change control management, team leadership, risk mitigation, cross-functional partnership
Preferred skills
Veeva RIM proficiency, prior regulatory agency liaison experience
Technologies
Microsoft Excel, PowerPoint, Project, Word, Veeva RIM
Responsibilities
Plan and manage CMC sections of regulatory submissions; lead multidisciplinary teams in responding to agency questions; interpret emerging global regulatory requirements; provide strategic guidance on manufacturing process changes; coach and evaluate direct reports
Seniority
Senior Director, strategic leadership with hands-on execution