Manager, Regulatory Affairs

Arbeitsbeschreibung

The Regulatory Affairs, Advertising and Promotion (RA Ad Promo) group seeks a Manager at Kite, a Gilead Company, in Santa Monica, CA. The Manager is responsible for managing the internal Promotional Review Committee (PRC) process and the submission of promotional materials for marketed prescription drug or biologic products to the US Food and Drug Administration (FDA). The RA Ad Promo group provides commercial regulatory strategy and leadership at Gilead and Kite to enable the business support patients and meet its commercial needs in a compliant manner.

Responsibilities

• Manage the Promotional Review Committee (PRC) process end-to-end and act as a project manager for the PRC, Marketing, and other cross-functional stakeholders in order to ensure accurate, timely, and compliant review of materials

• Schedule PRC meetings serving as the point of contact for meeting coordination

• Facilitate and document required changes and comments as part of PRC during meetings

• Manage product label updates and collaborate with cross-functional stakeholders to ensure materials are revised, resubmitted for PRC Review, and submitted to FDA on form 2253

• Ensure consistency and quality of PRC submissions

• Maintain the promotional material library to ensure active/approved materials are re-reviewed per internal guidelines

• Monitor daily operations and adherence to SOP(s)

• Create and manage timely submissions of promotional materials to the FDA (i.e. FDA 2253, Request for Advisory Comments)

• Ensure that projects are completed on schedule following established procedures and timelines as it relates to the PRC process and submissions to the FDA

• Participate in ongoing PRC Operational projects to enhance efficiencies in Kite PRC processes

• May represent group in cross-functional and Regulatory Affairs working groups and present project status updates to group

• Maintain Kite US Reference Library standards and associated Claims