Director, Regulatory Affairs

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role At the intersection of science, strategy, and compliance, this role offers a rare opportunity to shape how life‑changing therapies are brought to patients through compliant, compelling promotion. The Director, Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products and is accountable for the review, approval, and strategic oversight of promotional materials. In this role, the Director ensures compliance with applicable laws, regulations, and FDA guidance while providing independent, expert regulatory counsel to cross‑functional stakeholders. Operating with a high degree of autonomy, the Director enables the development of compliant and effective promotional strategies that support business objectives and drive organizational success. The Director leads and represents Regulatory Affairs on Promotional Review Committees, ensuring that U.S. promotional materials for prescription products meet regulatory requirements and align with company strategy. As the primary regulatory liaison to FDA promotional review divisions, including OPDP and APLB, the Director manages correspondence, addresses complex regulatory inquiries, and oversees submissions for advisory comment. The role requires the ability to propose innovative and compliant regulatory strategies and solutions to complex promotional concepts, balancing business objectives with regulatory risk. In addition, the Director leads the strategic evaluation and regulatory positioning of proposed product claims for assets in development, including oversight of Important Safety Information (ISI) and Brief Summary documents, as appropriate. The role drives the development, implementation, and continuous improvement of advertising and promotion processes, standards, and standard operating procedures to enhance operational efficiency and ensure sustained regulatory compliance. The Director also leads the assessment of evolving regulatory trends, guidance, and enforcement activities, proactively advising Regulatory Affairs teams, review committees, and cross‑functional stakeholders to inform business decisions and ensure compliance. The Director actively participates in labeling and global regulatory team discussions to ensure alignment of clinical development and labeling strategies with anticipated promotional claims and messaging. The role includes leading the development of regulatory strategy communications, including responses to FDA action letters, and overseeing interactions with OPDP and APLB. The Director also oversees the design and execution of enterprise‑wide training on promotional regulatory requirements to strengthen organizational capability and compliance awareness. As a key strategic leader, the Director collaborates closely with Marketing, Legal, Medical Affairs, Quality, and other stakeholders to enable compliant and effective promotional execution. The role partners with Quality on internal audits and CAPAs, providing regulatory leadership to ensure alignment with compliance requirements and to drive continuous improvement. Recognized as a subject matter expert in U.S. promotional regulations, the Director provides coaching and informal mentorship to team members, including onboarding support for new hires, fostering a culture of consistency, capability development, and regulatory excellence. Who You Are Minimum Qualifications Bachelor’s degree in a science or health‑related discipline; advanced degree (PhD, MD, MS, or PharmD) strongly preferred. Minimum 8+ years of pharmaceutical industry or related experience, with a minimum of 5 years as a primary reviewer of advertising and promotional materials. In‑depth knowledge of FDA regulations governing the development, review, and approval of prescription drug promotional materials, including OPDP and APLB processes. Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges, balancing business objectives with regulatory risk. Strong diplomacy, interpersonal, and negotiation skills, with a track record as a consensus builder across cross‑functional teams. Preferred Qualifications Experience leading or supporting drug promotion activities and product launches within a pharmaceutical or biopharmaceutical environment. Comprehensive understanding of the Regulatory Affairs landscape for prescription drugs, including labeling strategy and clinical development alignment. Demonstrated ability to lead enterprise‑wide training initiatives and foster a culture of continuous improvement and regulatory compliance. Excellent verbal and written communication skills, with the ability to translate complex regulatory concepts for diverse audiences. Location Boston, MA, USA (Seaport); Hybrid 3 days per week in office. Travel Pay Range $210,900.00 - $316,300.00. Benefits Health insurance, paid time off (PTO), retirement contributions, and other perquisites. Position may be eligible for sales or performance‑based bonuses. For more information click here. What We Offer We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! #J-18808-Ljbffr