Director, US Regulatory Advertising – Promotion

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🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $177k - $260k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Ipsen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Ipsen is a global biopharmaceutical group that focuses on improving patient lives through innovative medicines in the areas of oncology, rare diseases, and neuroscience. With a commitment to addressing high unmet medical needs, Ipsen leverages its expertise and resources to develop new therapies and collaborations, accelerating the path from scientific innovation to patient care. The company strives to make a significant impact in the lives of patients suffering from serious conditions such as cancer, rare diseases, and neurological disorders.

📋 Description

• Serve as the internal subject matter expert on FDA Advertising & Promotion issues for assigned products • Provide regulatory advice and solutions on promotional materials to maintain FDA compliance • Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, and company policy • Lead assigned Promotional Review Committees and support Medical Review Committees • Act as regulatory reviewer on copy approval teams • Develop SOPs and work instructions to streamline workflows • Liaise with OPDP/FDA as the company point of contact for advertising and promotional matters • Manage OPDP/APLB interactions, regulatory inquiries, advisory-comment submissions, and discussions with staff • Foster collaboration between Regulatory and PRC partner functions • Share commercial regulatory guidance with US Commercial Teams • Lead PRC teams in compliant execution of marketing tactics and programs • Implement revised product labels, manage content lifecycle, and establish risk information and training materials

🎯 Requirements

• Minimum of 8 years’ experience in the pharmaceutical industry • Minimum of 6 years in regulatory affairs • Expert knowledge of advertising promotion regulations and FDA Guidance documents • Technical experience in aspects of drug development and labeling • Experience with promotional and medical review supporting product communications • Experience working with FDA, including OPDP and APLB, on advertising and promotion matters • Ability to understand and interpret clinical trial data • Expert understanding of FDA promotional regulations, product and therapeutic knowledge, and evidentiary standards for product claims • Excellent oral and written communication and negotiation skills • Strong attention to detail • Ability to identify issues, convey product facts, and offer risk-mitigation options • Ability to articulate impacts associated with insufficient risk mitigation • Ability to influence and interact effectively across functions and with regulators • Understanding of commercial objectives and FDA compliance standards • Ability to develop innovative ideas and best practices • Ability to anticipate and solve problems • Leadership, teamwork, and cross-functional collaboration skills • Ability to manage multiple activities or projects • Bachelor’s degree in a scientific discipline • Fluent in English

🏖️ Benefits

• Short-term incentives program eligibility • Long-term incentives program eligibility • Inclusive and equal-opportunity workplace • Application adjustments or support available upon request • Investment in employees and life-changing projects