Senior Regulatory Strategist, Advertising & Promotion (work from home)

When our values align, there's no limit to what we can achieve. 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. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Our client partnerships continue to grow! 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

Responsibilities • Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams • Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios • Independently 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 strategy • Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs • Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy • Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications • Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations • Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes • Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders • Mentor junior team members and contribute to building organizational regulatory capability

Qualifications • 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion • Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities • Proven ability to act as a strategic advisor and trusted partner to senior stakeholders • Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams • Demonstrated ability to independently review promotional materials and make sound regulatory decisions • Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly • Excellent communication, influence, and stakeholder management skills • Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset Preferred

Qualifications •

Experience supporting product launches or high-visibility brands • Familiarity with global regulatory considerations (nice to have) • Prior experience leading or facilitating MLR/PRC committees What Sets This Role Apart • Opportunity to operate as a strategic, enterprise-level regulatory leader • High visibility across commercial and medical leadership teams • Ability to directly influence brand strategy while ensuring compliance and patient safety #LI-LB1 EEO Disclaimer Parexel 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. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™