Senior / Regulatory Affairs Consultant - Advertising and Promotion

6 days ago

Dover, DE, United States PAREXEL Full time

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).

#LI-LB1

#LI-REMOTE

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.

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