Principal Consultant, Labeling Strategy

Job overview

The Principal Consultant, Labeling Strategy role is remote across the United States, with a stated pay range of $210,000–$300,000 USD. Opus Regulatory’s Labeling Strategy Practice supports pharmaceutical and biotechnology clients across products, therapeutic areas, and global markets. The company provides regulatory affairs consulting services. The consultant provides strategic regulatory guidance and hands-on labeling execution as an embedded member of client teams. The role leads labeling initiatives, develops and maintains product labeling through development, registration, and commercialization, and helps align scientific evidence, regulatory requirements, and program objectives.

What you'll do

• Advise client teams on labeling strategy, content development, submissions, processes, and best practices
• lead preparation, review, and maintenance of Target Product Labels, Company Core Data Sheets, U.S. prescribing information, EU product information, and other regional labeling
• guide early-stage labeling strategy
• lead cross-functional discussions and build consensus
• assess regulatory implications of proposed changes
• manage global labeling timelines and deliverables
• support regulatory authority requests and labeling negotiations as needed
• apply labeling process and systems knowledge
• monitor evolving requirements and guidance.

What we're looking for

Skills & competencies

principal consultant

labeling strategy

remote

united states

opus regulatory

pharmaceutical

biotechnology

regulatory affairs

global labeling

labeling submissions

$210k–$300k/year

full-time

Work arrangement

• Weekend coverage required

Benefits & perks

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

Why this role

The posting welcomes candidates with Senior Manager through Vice President experience levels and requires 8+ years of pharmaceutical or biotechnology regulatory affairs experience focused on labeling. Benefits include medical, dental, vision and prescription coverage, life insurance, short-term disability, an employee assistance program, a 401(k), 20 vacation days, 5 sick days, and 10 paid company holidays annually.

About the employer

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