Principal Consultant, Labeling Strategy

Job overview

The Principal Consultant, Labeling Strategy is a fully remote role serving pharmaceutical and biotechnology clients across the United States. The US-remote annual pay range is $210,000–$300,000. Opus Regulatory’s Labeling Strategy Practice supports clients across products, therapeutic areas, and global markets. The consultant combines strategic regulatory advice with hands-on labeling execution throughout development, registration, and commercialization. By guiding labeling decisions and cross-functional alignment, the role helps clients maintain compliant product information and advance program objectives.

What you'll do

• Advise client teams on labeling strategy, content, submissions, processes, and best practices
• lead preparation, review, and maintenance of target product labels, company core data sheets, US prescribing information, EU product information, and other regional labeling
• guide early-stage strategy
• lead cross-functional discussions
• assess regulatory implications of changes
• manage timelines and deliverables
• support agency requests and negotiations as needed
• monitor evolving requirements and guidance.

What we're looking for

Skills & competencies

principal consultant

labeling strategy

regulatory affairs

pharmaceuticals

biotechnology

fully remote

us remote

opus regulatory

$210k–$300k

global labeling

product information

full-time

paid time off

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, and prescription coverage
• life insurance
• short-term disability
• EAP
• 401(k)
• 20 vacation days, 5 sick days, and 10 paid company holidays annually.

Why this role

Requires 8+ years of pharmaceutical or biotechnology regulatory affairs experience focused on labeling strategy, content development, and lifecycle management; bachelor’s degree required and advanced scientific degree preferred.

About the employer

Opus Regulatory is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.