Director, Regulatory Affairs Advertising & Promotion

You will provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products, including launch products/indications, or complex and/or high-priority products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines, and company policy. Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings. Advanced degree desirable (MS, PhD, PharmD, or JD) Minimum 5 years regulatory experience in the pharmaceutical space In-depth knowledge and understanding of US regulations for drug promotion/advertising and US labeling Experience in leading activities for OPDP submissions, including time of first use sub-missions, requests for advisory comments, and 30-day submissions for Subpart H products Experience with regulatory activities involved in a product or indication launch Proven ability to analyze and interpret efficacy and safety data Understanding of business goals of the in-volved business franchise, marketing concepts and tools Must perform independently with strong negotiation and decision-making skills Must be able to work in a multi-disciplinary environment Proven analytical and problem-solving skills associated with problem review and inquiries and proven ability to provide creative solutions to complex problems Novartis Compensation Summary: The salary for this position is expected to range between $176,400 and $327,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information.

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