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

Parexel; Oregon; Hybrid; USD 130,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Strategist, Advertising & Promotion to join our team in a remote capacity. You will serve as a trusted regulatory advisor supporting clinical research and commercial activities that advance new treatments for patients.

This role requires interpreting FDA guidance, ensuring compliance, and collaborating with Medical Affairs, Legal, Commercial, and Marketing to shape product strategy.

Qualifications

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
• 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,

Job description

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.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies.

We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the Role

We are seeking a Senior Regulatory Strategist, Advertising & Promotion to join our team in a remote capacity. As a Senior Regulatory Strategist, Advertising & Promotion, you will serve as a trusted regulatory advisor supporting clinical research and commercial activities that advance new treatments for patients.

This position plays a key role in ensuring regulatory compliance, interpreting FDA guidance, and delivering strategic regulatory insights that shape product strategy. You'll collaborate with cross-functional teams including Medical Affairs, Legal, Commercial, and Marketing, follow industry-standard regulatory processes, and contribute to regulatory excellence from strategy development through implementation.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership, risk mitigation, and advancing patient safety. With diverse teams and continuous learning opportunities, the Senior Regulatory Strategist, Advertising & Promotion can explore career paths and expand skills across regulatory affairs and clinical research.

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
• 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,