We are seeking a Senior Director, Regulatory Affairs, Advertising and Promotion (Manager) to lead a team of regulatory professionals in reviewing and approving U.S. promotional materials. This role requires deep expertise in FDA regulations and a strong background in pharmaceutical regulatory affairs, ideal for experienced leaders in the healthcare industry.
Senior Director, Regulatory Affairs, Advertising and Promotion (Manager)
requirements
Minimum Qualifications: • Bachelor’s degree in science or health related discipline. Advanced degree (PhD, MD, MS, PharmD) highly preferred. • Minimum 10 or more years of pharmaceutical industry or related experience with an emphasis in regulatory or scientific disciplines, with a minimum of seven years of direct experience as the primary reviewer of advertising and promotional materials. • Ability to provide supervision and support across multiple therapeutic areas. • Demonstrated ability to make day-to-day regulatory decisions for escalations. • Demonstrated in-depth expertise in FDA regulations governing promotion development, implementation, and promotional review processes, with the ability to shape organizational interpretation and application. • Comprehensive understanding of the clinical development lifecycle, regulatory policy, labeling strategy, and FDA approval processes, applied to inform and guide cross-functional strategic decisions. • Proven ability to lead and resolve highly complex promotional regulatory challenges, driving innovative, compliant solutions across products and therapeutic areas. • Exceptional diplomacy, influence, and negotiation skills, recognized for building consensus and effectively engaging senior stakeholders; demonstrated strategic and analytical leadership in shaping business and regulatory outcomes. Preferred Qualifications: • Experience supporting or leading drug promotion activities and product launches, with a solid understanding of commercialization and regulatory considerations across the product lifecycle. • Comprehensive understanding of the pharmaceutical Regulatory Affairs landscape, including prescription drug promotion and labeling requirements. • Demonstrated ability to lead and foster a culture of continuous learning, operational excellence, and process improvement within a matrixed organization. Location: Boston, MA, USA (Seaport); Hybrid 3 days per week in office Travel: Pay range for this position: $258,300.00 - $387,500.00 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. 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!