Remote Part-Time Regulatory Promotions Consultant

ProPharma; Raleigh (NC); Hybrid; USD 83,000 - 165,000; Part time

Job summary

ProPharma invites a part-time Regulatory Promotional Review Consultant to guide compliant promotional review across brands. You will lead PRC discussions, provide regulatory risk assessments, and ensure materials align with FDA advertising requirements.

This role emphasizes independent work with clients and cross-functional partners in a hybrid setup. Required: 5+ years in pharma/biotech regulatory advertising, a Bachelor's degree, and strong experience with OPDP submissions.

Qualifications

• Minimum 5 years in pharmaceutical/biotech regulatory advertising and promotion.
• Bachelor’s degree required; PharmD preferred.
• Knowledge of FDA advertising and promotional guidance.
• Experience leading Promotional Review Committee activities.
• Experience with OPDP submissions and regulatory communications.

Responsibilities

• Review promotional and non-promotional materials for PRC with FDA promotion compliance.
• Lead PRC discussions and guide promotion review processes.
• Review launches, growth, and derivative materials for compliance.
• Advise on regulatory risk and escalation to management.
• Coordinate with clients and internal teams to align review timing.

Skills

Regulatory advertising

FDA guidelines

OPDP submissions

PRC leadership

Promotional review

Education

Bachelor's degree

PharmD preferred

Tools

MS Office

Adobe Acrobat

Veeva Vault Promo Mats

Job description

ProPharma invites a part-time Regulatory Promotional Review Consultant to guide compliant promotional review across brands. You will lead PRC discussions, provide regulatory risk assessments, and ensure materials align with FDA advertising requirements.

This role emphasizes independent work with clients and cross-functional partners in a hybrid setup. Required: 5+ years in pharma/biotech regulatory advertising, a Bachelor's degree, and strong experience with OPDP submissions.