Senior Regulatory Lead – Advertising & Promotion, Remote

Parexel; Jackson (MS); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Strategist, Advertising & Promotion, to join our expanding client partnership and work remotely. You will influence regulatory strategy, review promotional materials, and partner with Medical Affairs, Legal, and Commercial teams to ensure compliant, scientifically accurate communications.

You will interpret FDA guidance, anticipate enforcement trends, mentor junior staff, and lead regulatory review discussions to mitigate risk while enabling timely product

Qualifications

• 7+ years in Regulatory Affairs with emphasis on Advertising & Promotion.
• Deep knowledge of FDA regulations, guidance and enforcement trends for promotional activities.
• Ability to act as strategic advisor to senior stakeholders.
• Experience collaborating with Medical Affairs, Legal and Commercial teams.
• Independent review of promotional materials and regulatory decisions.
• Experience interpreting FDA guidance and adapting strategies.

Responsibilities

• Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams.
• Act as a SME in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios.
• Independently review and approve promotional and non-promotional materials for compliance with FDA regulations and industry standards (e.g., OPDP).
• Interpret FDA guidance to identify risks and opportunities informing regulatory strategy.
• Pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs.
• Provide strategic input early in development to influence messaging and communication strategy.
• Partner with Legal and Medical Affairs to ensure balanced, compliant communications.
• Lead risk assessment discussions and provide solutions-oriented recommendations.
• Support and, where needed, lead regulatory review committees (e.g., PRC/MLR).
• Stay current with regulatory trends and enforcement actions, sharing insights with stakeholders.
• Mentor junior team members and contribute to regulatory capability.

Skills

Regulatory expertise

FDA Advertising & Promotion

Strategic advisory

Cross-functional collaboration

Communication

Stakeholder management

MLR/PRC facilitation

Job description

Parexel is seeking a Senior Regulatory Strategist, Advertising & Promotion, to join our expanding client partnership and work remotely. You will influence regulatory strategy, review promotional materials, and partner with Medical Affairs, Legal, and Commercial teams to ensure compliant, scientifically accurate communications.

You will interpret FDA guidance, anticipate enforcement trends, mentor junior staff, and lead regulatory review discussions to mitigate risk while enabling timely product