Senior Regulatory Affairs Manager

仕事内容

• 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 content of the original label and label updates.
• Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets.
• Contributes to process improvements and/or other special projects within Regulatory Affairs.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.