Job Title

We are seeking a motivated Senior / Regulatory Affairs Consultant u2013 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. Youu2019ll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust. Key Responsibilities u2022 Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content. u2022 Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development. u2022 Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. u2022 Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements. u2022 Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. u2022 Support preparation of responses to regulatory inquiries related to promotional activities. u2022 Track and manage promotional submissions and approvals in regulatory systems u2022 Manage SOPs and electronic review systems. Qualifications u2022 Education: Bacheloru2019s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field. Experience: u2022 3u20135 years of pharmaceutical/biotech related industry experience. u2022 Direct experience in advertising and promotional regulatory review. u2022 Familiarity with FDA regulations governing promotional materials. Skills: u2022 Strong organizational skills with the ability to manage multiple projects under tight timelines. u2022 Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners. u2022 Attention to detail combined with strategic thinking. u2022 Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS). u2022 Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards. Competencies: u2022 Knowledge of US regulatory requirements for advertising and promotion. u2022 Demonstrated problem-solving ability and sound decision-making. u2022 Ability to work effectively in a matrix environment and collaborate across diverse teams. u2022 Strong interpersonal skills with cross-cultural awareness. u2022 Fluency in English (verbal and written). #LI-LB1 #LI-REMOTEEEO 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.