Job Description
Description
• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
• With guidance, defines the regulatory strategy for one or more Gilead/Kite products or projects.
• Evaluates changes to the local regulatory landscape and sharing risks and opportunities with the global study team when necessary.
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
• Leads the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Clinical Trial Notification (CTN).
• Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for new drug submission, etc.
• Provides input to the c...