Senior Regulatory Affairs Consultant - Ad Promo

at Parexel in Boise, Idaho, United States

Senior Regulatory Consultant Advertising & Promotion (Strategic Lead)

We are seeking a highly strategic and experienced Senior Regulatory Consultant Advertising & Promotion to serve as a trusted advisor across cross-functional teams. 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.

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 (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

Qualifications

- 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 abili