Remote Senior Regulatory Strategist, Advertising Promotion

Regulatory Jobs; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Strategist, Advertising & Promotion, to join our team in a remote capacity in the United States. You will serve as a trusted regulatory advisor supporting clinical research and commercial activities, ensuring compliance with FDA guidance and shaping product strategy across Medical Affairs, Legal, Commercial, and Marketing.

You will independently review promotional materials, interpret evolving FDA guidance, and contribute to regulatory excellence from

Qualifications

• Deep 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.
• Strong experience collaborating with Medical Affairs, Legal, and Commercial teams.
• Demonstrated ability to independently review promotional materials and make sound regulatory decisions.
• Excellent communication, influence, and stakeholder management skills.
• Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset.

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, 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, driving efficient and compliant review processes
• Stay current with regulatory trends, FDA enforcement actions, and industry best practices, proactively sharing insights with internal stakeholders
• Mentor junior team members and contribute to building organizational regulatory capability

Skills

FDA regulations

Regulatory strategy

Stakeholder advisory

Cross-functional collab

Communication skills

Job description

Parexel is seeking a Senior Regulatory Strategist, Advertising & Promotion, to join our team in a remote capacity in the United States. You will serve as a trusted regulatory advisor supporting clinical research and commercial activities, ensuring compliance with FDA guidance and shaping product strategy across Medical Affairs, Legal, Commercial, and Marketing.

You will independently review promotional materials, interpret evolving FDA guidance, and contribute to regulatory excellence from