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.

Key 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.

Qualifications

•             Education: Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.

Experience:

•             3–5 years of pharmaceutical/biotech related industry experience.

•             Direct experience in advertising and promotional regulatory review.

•             Familiarity with FDA regulations governing promotional materials.

Skills:

•             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.

Competencies:

•             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).

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