Sr, Director, Regulatory Affairs-Labeling and Promotion - United States
Manage and oversee regulatory review of materials related to labeling, advertising and promotion of all products. Ensure structure and procedures are in place to support the labeling and promotional compliance activities. Ensure compliance with internal SOPs and heath authority regulations, including compilation and submission of any required documents to regulatory agencies.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• Lead development and maintenance of global package inserts including USPI and SmPC to support regulatory submissions
• Establish database to efficiently track local labels and label changes
• Establish and maintain Core Company Data Sheet and procedures related to CCDS
• Maintain up-to-date knowledge of laws, regulations and policies enforced by the regulatory authorities as they relate to labeling, advertising and promotion of pharmaceuticals. Advise appropriate departments within the company of these requirements
• Develop and implement strategies to maintain efficient and compliant process for review of advertising/promotional materials and other labeling materials
• Review and submit advertising/promotional materials and other materials as required ensuring full regulatory compliance for all products
• Build strong relationships with internal customers; including Commercial, Legal and Clinical.
• Build strong relationships with regulatory authorities