Job Description:

We are seeking a Regulatory Review and Ad Promo Specialist to review and approve advertising and promotional materials for pharmaceutical products. This role ensures compliance with FDA guidelines and regulations and supports the timely submission of promotional materials to the FDA. The ideal candidate will collaborate with cross-functional teams, assess regulatory risks, and maintain compliance standards.

Key Responsibilities:

• Review and submit promotional materials, including FDA Form 2253 submissions, ensuring accuracy and compliance.
• Serve as a regulatory representative on Promotional Review Committees (PRC) and Medical and Scientific Review Committees (MSRC).
• Monitor FDA guidance and regulatory changes, providing risk assessments to senior leadership.
• Maintain and enhance processes, procedures, and standard operating practices to ensure efficiency and compliance.
• Collaborate with internal teams to ensure promotional claims align with product registrations and regulations.

Qualifications:

• Bachelor’s degree in a scientific or healthcare discipline.
• 6–10 years of experience in Regulatory Affairs, including FDA submission of US Ad/Promo documents.
• Expertise in advertising and promotional review, FDA guidance, and compliance regulations.
• Proficiency with document management systems (e.g., Veeva Vault RIM) and platforms (e.g., Salesforce).
• Oncology therapeutic knowledge and pharmaceutical lifecycle management experience preferred.
• Strong organizational, communication, and cross-functional collaboration skills.

Additional Details:

• Fully remote position.
• Part-time: 25–30 hours per month.
• Duration: 6 months, with potential for extension or conversion to FTE.

This is an exciting opportunity for a regulatory professional to contribute to impactful projects while working in a flexible, remote environment.