Job Description
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 bolthires 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). #LI-LB1 #LI-REMOTE Apply tot his job