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
Biopharmaceuticals / Life Sciences
Deliverable
client delivery
Required skills
Regulatory strategy definition, risk identification 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 initiatives
Technologies
Regulatory submission systems, document management tools
Responsibilities
Represent regional Regulatory Affairs or serve as Regional Lead on cross-functional teams; Evaluate changes to the local regulatory landscape; Proactively identify regulatory risks and develop mitigation plans; Lead the preparation and timely filing of regulatory submissions; Lead cross-functional teams in authoring regulatory documents; Provide input to original label and label updates; Ensure product packaging and information compliance; Contribute to process improvements within Regulatory Affairs
