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

Parexel•Southport, NC

11d•Remote

About The Position

Parexel is seeking a Senior Regulatory Strategist, Advertising & Promotion to work remotely. The role serves as a trusted regulatory advisor supporting clinical research and commercial activities, ensuring regulatory compliance, interpreting FDA guidance, and providing strategic insights that shape product strategy. The position collaborates with Medical Affairs, Legal, Commercial, Marketing, and Clinical teams and contributes to regulatory excellence from strategy development through implementation. The Senior Regulatory Strategist provides strategic guidance on advertising and promotional materials, independently reviews and approves promotional content, and interprets evolving FDA guidance. This role operates in a fast-paced, growth-oriented environment focused on strategic regulatory leadership, risk mitigation, and patient safety, with opportunities to expand expertise across regulatory affairs and clinical research.

Requirements

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

Nice To Haves

Experience supporting product launches or high-visibility brands.
Familiarity with global regulatory considerations.
Prior experience leading or facilitating regulatory review committees.

Responsibilities

Serve as a strategic regulatory partner to stakeholders in Medical Affairs, Legal, Commercial, Marketing, and Clinical teams.
Act as a subject matter expert in FDA Advertising & Promotion regulations and provide high-level guidance on complex regulatory scenarios.
Independently review and approve promotional and non-promotional materials for compliance with applicable FDA regulations, guidance, and industry standards.
Interpret and apply FDA guidance, identifying risks and opportunities to inform regulatory strategy.
Adapt regulatory strategy to evolving FDA expectations, enforcement trends, and business needs.
Provide early strategic input into product development, messaging, claims, and communications strategy.
Partner with Legal and Medical Affairs to ensure communications are balanced, compliant, and scientifically accurate.
Lead risk assessment and mitigation discussions and offer solutions-oriented recommendations.
Support and, when needed, lead regulatory review committees and promote efficient, compliant review processes.
Monitor regulatory trends, FDA enforcement actions, and industry best practices, and share relevant insights with internal stakeholders.
Mentor junior team members and contribute to organizational regulatory capability.