Principal Consultant, Labeling Strategy

Multiple Openings | Remote | Senior Manager–Vice President Experience Levels

Opus Regulatory's Labeling Strategy Practice is hiring Principal Consultants to support pharmaceutical and biotechnology clients across a variety of products, therapeutic areas, and global markets.

In this role, you will combine strategic regulatory guidance with hands-on execution, helping clients develop and maintain labeling throughout product development, registration, and commercialization. As an embedded member of client teams, you will lead labeling initiatives, build cross-functional consensus, and guide labeling decisions that align scientific evidence, regulatory requirements, and program objectives.

We welcome candidates with experience at the Senior Manager through Vice President levels who enjoy solving complex labeling challenges and contributing directly to client success.

Key Responsibilities

• Serve as a regulatory labeling expert within client teams, advising on labeling strategy, content development, submissions, processes, and best practices.

• Lead the preparation, review, and maintenance of Target Product Labels (TPLs), Company Core Data Sheets (CCDSs), U.S. prescribing information, EU product information, and other regional or local labeling.

• Guide early-stage labeling strategy, partnering with development teams to identify labeling objectives, assess supporting evidence, and address potential gaps.

• Lead cross-functional labeling discussions, partnering with clinical, safety, medical, and regulatory stakeholders to resolve issues and drive consensus.

• Assess and communicate the regulatory implications of proposed labeling changes, including risks, regional considerations, and implementation strategies.

• Develop and manage labeling timelines and deliverables, coordinating content updates, submissions, and implementation across global markets.

• Support responses to regulatory authority requests and labeling negotiations, including preparation of supporting documentation and participation in agency meetings, as needed.

• Apply knowledge of end-to-end labeling processes, governance, and systems to support labeling operations and improve consistency and efficiency.

• Monitor evolving labeling requirements and guidance, advise client teams on their implications, and represent regulatory labeling in client meetings and related workstreams.

Qualifications

• 8+ years of pharmaceutical or biotechnology regulatory affairs experience focused on labeling strategy, content development, and lifecycle management.

• Bachelor's degree required; an advanced degree in a scientific discipline preferred.

• Demonstrated experience developing and maintaining core, U.S., EU, and other regional labeling, with a strong understanding of global labeling requirements.

• Experience supporting labeling during product development and commercialization, including TPL and CCDS development and maintenance.

• Ability to provide both strategic counsel and hands-on support, with an understanding of labeling operations, governance, and supporting systems.

• Experience across multiple therapeutic areas highly desirable.

• Strong project management skills, including the ability to coordinate labeling submissions, manage competing priorities, and support regulatory inspection activities.

• Strong communication and collaboration skills, with the ability to interpret scientific information, communicate regulatory risks, and guide cross-functional teams toward consensus.

• Ability to work independently, exercise sound judgment, and develop practical solutions to labeling and operational challenges.