The Senior Director of Advertising & Promotion prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs. The Senior Director is responsible for ensuring the pieces are in compliance with regulatory agencies requirements
Manages the Regulatory Promotional reviewers for prescription drugs who represent Regulatory Affairs on the promotional review committee for marketed products. This position may require reviewing promotional materials if the company requires it. This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives.
Provide guidance on proposed claims for products in development and development of ISI and brief summaries.
Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters. Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP) and other regulatory considerations that may impact business. Develop or revise procedures as needed.
Review packages for regulatory advice, resolution of FDA action letters and leads the company in discussions with OPDP.
Coordinate companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company products.
Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo.
Interacts with Quality related to internal audits and CAPAs, as needed.
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