Senior Regulatory Affairs Manager
Core
Defines regulatory strategy and leads the preparation and filing of regulatory submissions for Gilead/Kite products.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory submissions, briefing packages, and Module 1 documents for new drug submissions
Domain
Life Sciences / Pharmaceutical
Required skills
Regulatory strategy definition, risk evaluation and mitigation, cross-functional team leadership, regulatory document authoring, label content input, packaging compliance management
Preferred skills
Experience with Clinical Trial Notifications (CTN), process improvement within Regulatory Affairs
Technologies
None stated
Responsibilities
Represents regional Regulatory Affairs or serves as Regional Lead on cross-functional teams; Evaluates changes to the local regulatory landscape; Proactively identifies regulatory risks and develops mitigation plans; Leads the preparation and timely filing of regulatory submissions; Leads cross-functional teams in authoring regulatory documents; Provides input to original label and label updates; Ensures product packaging and information are updated according to product licenses