Job Details

We are seeking a motivated 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).

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