Principal Consultant, Labeling Strategy

About Opus Regulatory:

Founded in 1994, Opus Regulatory (Opus) is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations. Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level of Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients.

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.

At Opus Regulatory, we are committed to pay transparency and equitable
compensation practices. Actual compensation will be determined based on factors such
as experience, education, specialized expertise, geographic location, and internal
equity. In select circumstances, compensation may fall outside of the posted range.

US-Remote Pay Range

$210,000—$300,000 USD

Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.