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Responsibilities:

Serve as a regulatory reviewer for assigned products. Ensure regulatory compliance while effectively managing business risks.
Ensure that strategic regulatory subject matter expertise is provided on advertising and promotional materials/activities for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy.
Review relevant medical and clinical development non-promotional materials in accordance with company policies.
Direct the activities of regulatory personnel responsible for submissions of promotional materials to FDA.
Monitor US regulatory promotional environment by staying up-to-date on FDA regulations and guidances, reviewing untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance at major FDLI, DIA, and other industry/FDA meetings (when appropriate).

Requirements:

BA/BS Degree, Advanced degree preferable (MS, MD, PhD, PharmD, or JD).
Minimum 7 years regulatory experience.
Excellent understanding of US regulations for drug promotion/advertising and experience in the regulatory review of prescription drug advertising and promotion including product launches.
Proven ability to provide strategic direction and innovative, forward thinking regulatory guidance and analyze and interpret efficacy and safety data.
Experience in leading activities necessary for promotional OPDP submissions.

Experience with using new and social media platforms for promotion of prescription drugs in the US.

Katalyst HealthCares & Life Sciences Inc

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