Senior / Regulatory Affairs Consultant - Advertising and Promotion

Parexel • Raleigh, NC

10d

About The Position

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. We are seeking a motivated Senior / Regulatory Affairs Consultant – Advertising & Promotion to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You’ll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust.

Requirements

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• 3–5 years of pharmaceutical/biotech related industry experience.
• Direct experience in advertising and promotional regulatory review.
• Familiarity with FDA regulations governing promotional materials.
• Strong organizational skills with the ability to manage multiple projects under tight timelines.
• Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners.
• Attention to detail combined with strategic thinking.
• Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS).
• Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards.
• Knowledge of US regulatory requirements for advertising and promotion.
• Demonstrated problem-solving ability and sound decision-making.
• Ability to work effectively in a matrix environment and collaborate across diverse teams.
• Strong interpersonal skills with cross-cultural awareness.
• Fluency in English (verbal and written).

Responsibilities

• Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content.
• Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development.
• Participate in promotional review committees, ensuring alignment with FDA regulations and company standards.
• Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements.
• Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations.
• Support preparation of responses to regulatory inquiries related to promotional activities.
• Track and manage promotional submissions and approvals in regulatory systems
• Manage SOPs and electronic review systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees