Global Labeling Strategy Lead

Opus Regulatory Inc.; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Opus Regulatory Inc. is seeking a Principal Consultant, Regulatory Affairs Labeling Strategy to manage regulatory labeling requirements across multiple projects, including development and maintenance of labeling content.

You will lead labeling strategy, drive consensus with clients, and apply US, EU, and ICH regulations to support regulatory submissions and inspections. A strong background in labeling across therapies and global experience is essential.

Qualifications

• Minimum 4 years of experience in pharmaceutical regulatory affairs specializing in labeling strategy.
• Experience across multiple therapeutic areas is desirable.
• Demonstrated global/international regulatory experience is required.
• Proven project management skills to plan and coordinate labeling submissions.

Responsibilities

• Lead daily management of regulatory labeling requirements for one or more projects.
• Design and implement labeling strategy, drive consensus with client teams.
• Prepare, review, and update content for Target Product Label (TPL) and CCDS.
• Support agency communications and documentation for labeling changes.
• Provide RA guidance on CCDS content updates and implementation strategies.
• Apply US, EU and ICH labeling regulations to development and marketed products.
• Develop and manage labeling timelines and deliverables.
• Represent the RA labeling team in client meetings and workstreams.

Skills

Labeling Strategy

Regulatory Affairs

Project Management

Independent Work

Job description

Opus Regulatory Inc. is seeking a Principal Consultant, Regulatory Affairs Labeling Strategy to manage regulatory labeling requirements across multiple projects, including development and maintenance of labeling content.

You will lead labeling strategy, drive consensus with clients, and apply US, EU, and ICH regulations to support regulatory submissions and inspections. A strong background in labeling across therapies and global experience is essential.