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Senior Regulatory Strategist, Advertising & Promotion (work from home)At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.As a result, we are looking to hire an additional highly strategic and experienced Senior Regulatory Strategist, Advertising & Promotion to join our team. This individual will act as a trusted advisor, collaborating across cross-functional teams within a large, dedicated client partnership—helping to influence regulatory strategy and deliver meaningful impact, all while working remotely.This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.Key ResponsibilitiesServe as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teamsAct as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenariosIndependently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements)Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategyDemonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needsProvide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategyPartner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communicationsLead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendationsSupport and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processesStay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholdersMentor junior team members and contribute to building organizational regulatory capabilityQualifications7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & PromotionDeep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activitiesProven ability to act as a strategic advisor and trusted partner to senior stakeholdersExtensive experience collaborating with Medical Affairs, Legal, and Commercial teamsDemonstrated ability to independently review promotional materials and make sound regulatory decisionsStrong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordinglyExcellent communication, influence, and stakeholder management skillsStrong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindsetPreferred QualificationsExperience supporting product launches or high-visibility brandsFamiliarity with global regulatory considerations (nice to have)Prior experience leading or facilitating MLR/PRC committeesWhat Sets This Role ApartOpportunity to operate as a strategic, enterprise-level regulatory leaderHigh visibility across commercial and medical leadership teamsAbility to directly influence brand strategy while ensuring compliance and patient safetyEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.
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