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Regulatory Labeling Manager Jobs (NOW HIRING)

Amgen, Inc.

Labeling Strategist - Manager

Career Category Regulatory Join Amgen's Mission of Serving Patients At Amgen, if you feel like you ... Labeling Strategist Manager What you will do Let's do this. Let's change the world. The purpose of ...

Amgen

OR · On-site

Career Category Regulatory Join Amgen's Mission of Serving Patients At Amgen, if you feel like you ... Labeling Strategist Manager What you will do Let's do this. Let's change the world. The purpose of ...

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How much do regulatory labeling manager jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for regulatory labeling manager in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

How does a Regulatory Labeling Manager typically collaborate with cross-functional teams during the product development process?

As a Regulatory Labeling Manager, you will regularly collaborate with cross-functional teams including regulatory affairs, medical, legal, marketing, and product development. Your role involves ensuring that product labels meet both regulatory requirements and company standards by gathering input from these teams and facilitating consensus on label content. You’ll often lead meetings to align stakeholders, review draft labeling, and coordinate responses to regulatory authority feedback, making strong communication and project management skills essential. This collaborative environment also provides opportunities to broaden your expertise and visibility within the company, supporting long-term career growth.

What is the difference between Regulatory Labeling Manager vs Regulatory Affairs Specialist?

AspectRegulatory Labeling ManagerRegulatory Affairs Specialist
CertificationsRegulatory Affairs Certification (RAC), FDA certificationsRAC, FDA certifications
Work EnvironmentLeading labeling projects, cross-functional teamsSupporting regulatory submissions, research
Employer & Industry UsagePharmaceuticals, medical devices, biotechPharmaceuticals, medical devices, biotech

The Regulatory Labeling Manager focuses on developing, reviewing, and maintaining product labeling to ensure compliance with regulations. In contrast, the Regulatory Affairs Specialist handles broader regulatory submissions and compliance tasks. Both roles require similar certifications and are common in the same industries, but the Labeling Manager has a more specialized focus on labeling strategies and documentation.

What does a Regulatory Labeling Manager do?

A Regulatory Labeling Manager oversees the development, review, and approval of product labels and packaging to ensure compliance with all relevant regulations and guidelines. They coordinate with various departments, such as regulatory affairs, legal, marketing, and product development, to ensure that all labeling information is accurate and aligns with local and international laws. Their responsibilities often include managing labeling submissions to regulatory authorities, monitoring regulatory changes, and updating labels accordingly to maintain compliance.

What are the key skills and qualifications needed to thrive as a Regulatory Labeling Manager, and why are they important?

To thrive as a Regulatory Labeling Manager, you need expertise in regulatory compliance, labeling requirements, and scientific documentation, often supported by a degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and global labeling databases is typically required. Strong attention to detail, project management, and effective cross-functional communication skills set top performers apart in this role. These skills are crucial for ensuring accurate, compliant labeling that meets health authority standards and supports product success in global markets.
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Regulatory Labeling Manager jobs near you
Principal Consultant, Labeling Strategy

Principal Consultant, Labeling Strategy

Opus Regulatory

Miami, FL

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday

Job description

About Opus Regulatory:
For more than 30 years, Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of senior-level leaders and innovators provides project-specific contributions or ongoing support through the regulatory process. Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies.

The Principal Consultant, Regulatory Affairs Labeling Strategy is primarily responsible for the daily management of regulatory requirements for labeling strategy or labeling operations for one or more projects, designing and implementing labeling strategy, providing leadership to drive labeling consensus, and developing relationships with client subject matter experts and regulatory authorities. We have a robust client portfolio offering a variety of projects across therapeutic areas and regions.

Responsibilities include:

· Labeling experience across Development, Core, US, EU and Rest of World (ROW) Labeling.

· Understanding of end-to-end labeling process and systems.

· Lead preparation, review, and update content for the development and maintenance of Target Product Label (TPL), Company Core Data Sheet (CCDS), and local labeling and labeling components.

· Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory labeling, process, filing, best practices, etc. in conjunction with client leadership.

· Provide support and guidance to regulatory teams on RA requirements for one or more drug products by evaluating and communicating risks associated with CCDS content updates and implementation strategies.

· Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.

· Develop and drive regulatory labeling timelines and deliverables.

· Understanding of labeling governance and process work.

· Support agency requests and documentation process for impact to labeling; participate in agency meetings as requested.

· Maintain knowledge of changing regulatory requirements and advise teams as appropriate.

· Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.

Qualifications:

· Must have a minimum of 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy.

· Bachelor's degree required; Advanced degree in a science discipline preferred.

· Experience across multiple therapeutic areas is highly desirable.

· Demonstrated global and international experience is required.

· Proven project management skills to support the planning and coordination of labeling submissions and support appropriate regulatory inspections.

· Ability to work independently and innovatively in tackling operational challenges.

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.