Hiring: Senior Director, Regulatory Affairs, Advertising and Promotion (Manager) Company: EMD Serono, Inc. Location: Boston, MA Job Posted Time: 2026-09-16 15:46:26 Employment Type: Hybrid Target Skills & Keywords : Regulatory Compliance About the job 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. •Demonstrated capacity 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. •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!