Associate Director, Regulatory Affairs Advertising and Promotion

📋 Description

• • As an Associate Director of Regulatory Affairs for Advertising and Promotion at Biogen, you will be at the forefront of ensuring our groundbreaking neuroscience therapies are communicated accurately and compliantly to healthcare professionals, payors, and patients across the United States.
• • This pivotal remote-based role demands a strategic regulatory mind, capable of providing expert advice on a wide array of communications, including disease education, promotional materials, and scientific information, all while aligning with Biogen's overarching business objectives.
• • You will be the primary liaison with the Office of Prescription Drug Promotion (OPDP), a critical function that requires a deep understanding of FDA regulations and guidelines to maintain strong relationships and ensure smooth interactions.
• • Your responsibilities will extend to reviewing branded and unbranded concepts, ensuring all promotional materials are not only competitive and compelling but also strictly adhere to FDA-approved labeling, applicable FDA regulations, and the stringent requirements for 2253 submissions.
• • The role involves proactive risk assessment and the development of effective mitigation strategies, ensuring that all external communications are both impactful and legally sound.
• • You will play a key role in shaping creative and solution-oriented feedback, balancing the need to meet business goals with the imperative of regulatory compliance.
• • Collaboration is central to this position; you will forge and maintain robust working relationships with a diverse group of internal stakeholders, including Commercial, Medical, Legal, Compliance, Regulatory Strategy and Labeling, and Medical/Marketing Operations teams.
• • A significant aspect of the role is ensuring consistency in regulatory feedback and communications across different product franchises, working closely with management and fellow Regulatory Ad Promo team members.
• • You will also contribute to the department's efforts in monitoring the ever-evolving regulatory landscape, proactively communicating updates and their implications to internal stakeholders.
• • While the primary focus is on U.S. communications, the role may also involve reviewing global, corporate, clinical trial, and pipeline materials, offering a broad exposure to regulatory affairs.
• • The ideal candidate is a positive, agile individual who thrives in a fast-paced, compliant environment, demonstrating integrity in all actions.
• • You will be instrumental in advancing external initiatives targeting healthcare providers, payors, and patients, contributing directly to Biogen's mission of meaningfully changing the lives of individuals living with serious neurological diseases.
• • This position requires the ability to manage and prioritize multiple, often competing, responsibilities effectively, supporting a dynamic and expanding business.
• • You will leverage your expertise to dissect and interpret complex disease information and product efficacy/safety data, translating intricate scientific and clinical details into clear, compliant communications.
• • The role demands strong negotiation and interpersonal skills, essential for influencing stakeholders, building consensus, and fostering productive partnerships across interdisciplinary teams.
• • Adaptability is key, as you will need to respond effectively to dynamic environments and evolving business needs, ensuring regulatory strategies remain relevant and effective.
• • Developing and maintaining a strong, collaborative relationship with OPDP is a core requirement, underscoring the importance of trust and clear communication.
• • Excellent verbal, written, and presentation skills are paramount for conveying complex regulatory information clearly and persuasively to various audiences.
• • This role offers a unique opportunity to contribute to a leading biotechnology company at the forefront of neuroscience innovation, making a tangible difference in patient lives through compliant and effective communication strategies.