Parexel

Senior Regulatory Affairs Consultant – Advertising and Promotion

Parexel

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Senior

About the role

  • 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.

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.
Benefits
  • EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory reviewpromotional materials complianceFDA regulationsSOP managementproject managementadvertising reviewpromotional submissionsstrategic thinkingattention to detailmedical education
Soft skills
organizational skillscommunication skillscollaborationcross-functional teamworkability to manage multiple projectsexplanation of regulatory conceptsattention to detailstrategic thinking