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
Requirements
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
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
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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.
Benefits
Health insurance
Additional Information
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.
The partnership continues to grow!
As a result, we are seeking an additional highly strategic and experienced Senior Regulatory Consultant - Advertising & Promotion to serve as a trusted advisor across cross-functional teams on this dedicated client partnership. This individual will bring deep expertise in FDA advertising and promotion regulations, providing guidance that shapes compliant, effective, and innovative healthcare communications.
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.
Parexel · Remote