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Parexel · 1 week ago

Regulatory Affairs Consultant - Advertising and Promotion

United States

Full-time

Remote

Mid Level

3+ years exp

Parexel is seeking a motivated Regulatory Affairs Consultant – Advertising & Promotion to work as a trusted partner within a major client engagement. In this role, you will ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements while supporting product launches and ongoing promotional activities.

Pharmaceuticals

H1B Sponsor Likely

Hiring Manager

Lisa B.

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

Qualification

Advertising regulatory reviewFDA regulations knowledgeRegulatory systems proficiencyProject managementFluency in EnglishCommunication skillsAttention to detailProblem-solving abilityInterpersonal skills

Required

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)

Company

Parexel

Glassdoor3.9

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)