Remote Director, Regulatory Promotions & Labeling

ProPharma Group; Northern (KY); Hybrid; USD 150,000 - 210,000; Full time

Job summary

ProPharma Group in the United States seeks a Director, Promotional Review & Labeling Services to lead regulatory review of advertising for consumer, HCP, and managed care materials across brands. You will guide PRC meetings, oversee review workflows, and provide strategic regulatory input to marketing and launch teams.

Candidates bring 7+ years in pharma/biotech regulatory advertising, strong project management, and experience with OPDP submissions and FDA guidances.

Qualifications

• Minimum 7+ years in regulatory advertising and promotion in pharma/biotech.
• Experience leading promotional review and OPDP submissions.
• Strong knowledge of FDA advertising guidance and regulatory processes.

Responsibilities

• Provide compliant regulatory solutions for promotional and advertising review.
• Lead Promotion Review Committee meetings and oversight of review workflows.
• Provide regulatory guidance on campaigns, launches and label changes.
• Coordinate with agencies, stakeholders and operations for submissions.
• Mentor and advise job owners on timing and review processes.
• Stay current on FDA rules and promotional environment.

Skills

Regulatory advertising

OPDP submissions

FDA guidelines

Strategic regulatory guidance

Project management

Remote collaboration

Cross-functional leadership

Communication skills

Education

Bachelor's degree in Life Sciences/Marketing/Business

PharmD preferred

Tools

Veeva Vault PromoMats

Microsoft Office

Adobe Acrobat

Job description

ProPharma Group in the United States seeks a Director, Promotional Review & Labeling Services to lead regulatory review of advertising for consumer, HCP, and managed care materials across brands. You will guide PRC meetings, oversee review workflows, and provide strategic regulatory input to marketing and launch teams.

Candidates bring 7+ years in pharma/biotech regulatory advertising, strong project management, and experience with OPDP submissions and FDA guidances.