Reporting to the Director, Regulatory Affairs Clinical, the Manager, Regulatory Affairs, is a critical role within the Regulatory Affairs, Clinical organization. Responsibilities include conducting regulatory reviews of materials related to labeling, advertising and promotion of drug and generic drug products. The manager also serves as the permanent member of the Promotional Review Committee (PRC).
Serves as the permanent regulatory representative on the Promotional Review Committee (PRC)
Utilizing the Veeva Vault system, conducts regulatory review of materials related to labeling, advertising and promotion of brand and generic drug products
Provides relevant comments on advertising/promotional materials as well as final approval/disapproval
Supports compliance with internal SOPs and FDA requirements, including compilation and submission of any required documents to regulatory agencies.
Maintains up-to-date knowledge of laws, regulations and policies enforced by the FDA. as they relate to labeling, advertising and promotion of pharmaceuticals and provides regulatory advice accordingly.
Monitors impact of changing regulations on submission strategies and updates internal stakeholders accordingly.
Communicates with consultants, attorneys and external parties as needed.
OPDP submissions (Form FDA 2253
Compilation of cover letters, submissions and regulatory communications