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Manager Global Labeling Operations Jobs (NOW HIRING)

Labeling Specialist

Cupertino, CA · On-site

$62 - $67/hr

Manages marketing claims. * Coordinates internal marketing and post-market material review/approval. * Establishes systems for physical labeling controls. * Maintains labeling in accordance to global ...

Moderate knowledge of document management systems (e.g., EtQ Reliance). * Ability to perform minor level tasks in SOLIDWORKS. * Basic knowledge of FDA and global regulations as it relates to labeling ...

This position is a subject matter expert in global medical device labeling, regulations and ... Project management skills Education/Experience Required: * Minimum of 2 years experience in ...

... to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant. * Provide input to the end-to-end labeling process. * Ability to lead and manage ...

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Manager Global Labeling Operations information

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$63.5K

$118.5K

How much do manager global labeling operations jobs pay per year?

As of Sep 13, 2026, the average yearly pay for manager global labeling operations in the United States is $63,456.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,000.00 and $77,500.00 per year, depending on experience, location, and employer.

What is a Manager Global Labeling Operations?

A Manager Global Labeling Operations oversees the development, review, and maintenance of product labeling for pharmaceuticals or medical devices on a global scale. They ensure that labeling meets regulatory requirements in different countries and manage cross-functional teams to align labeling content with company and legal standards. This role often involves coordinating updates, supporting product launches, and handling label changes due to regulatory or safety updates. Strong project management and regulatory knowledge are essential for this position.

What are the key skills and qualifications needed to thrive as a Manager Global Labeling Operations?

To thrive as a Manager Global Labeling Operations, you need expertise in regulatory affairs, labeling requirements, and project management, often supported by a relevant science degree and experience in the pharmaceutical or medical device industry. Familiarity with regulatory submission systems, labeling management software, and knowledge of global health authority regulations are typically required. Strong leadership, cross-functional communication, and problem-solving skills help you navigate complex international projects and teams. These competencies ensure timely, compliant labeling that supports product approvals and global market success.

What are some common challenges faced by a Manager Global Labeling Operations, and how can they be effectively addressed?

A Manager Global Labeling Operations often contends with challenges such as coordinating labeling requirements across multiple international markets, ensuring compliance with frequently changing regulations, and managing cross-functional collaboration with regulatory, quality, and supply chain teams. Staying organized and maintaining clear communication channels are key to overcoming these hurdles. Leveraging robust project management tools and keeping up-to-date with global regulatory trends can help streamline processes and minimize errors, ensuring timely and accurate label updates.

What is the difference between Manager Global Labeling Operations vs Labeling Specialist?

AspectManager Global Labeling OperationsLabeling Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, pharmacy, or related field; often with project management certificationsUsually holds a relevant degree or certification in life sciences or regulatory affairs
Work EnvironmentManages teams across multiple regions, oversees global labeling strategies, and collaborates with regulatory agenciesFocuses on creating, reviewing, and updating labeling content within a specific project or region
Employer & Industry UsageCommonly employed by pharmaceutical and biotech companies in global regulatory operationsFound within pharmaceutical companies, focusing on labeling content and compliance

The Manager Global Labeling Operations oversees global labeling strategies and manages teams, while the Labeling Specialist handles the detailed creation and review of labeling content. The manager has broader responsibilities, including strategic planning and cross-regional coordination, whereas the specialist focuses on day-to-day labeling tasks within specific projects.

What cities are hiring for Manager Global Labeling Operations jobs?

Cities with the most Manager Global Labeling Operations job openings:

What states have the most Manager Global Labeling Operations jobs?

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What are popular job titles related to Manager Global Labeling Operations jobs?

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Infographic showing various Manager Global Labeling Operations job openings in the United States as of September 2026, with employment types broken down into 60% Full Time, and 40% Contract. Highlights an 80% In-person, and 20% Remote job distribution, with an average salary of $63,456 per year, or $30.5 per hour.

Director, Global Labeling - Regulatory Affairs

Billerica, MA • On-site

$159K - $210K/yr

Other

Posted 10 days ago


Job description

Work Location: Billerica, Massachusetts

Shift: No

Department: HC-RD-RRF Regulatory Affairs for Advertising Promotion

Recruiter: Molly Scheu

Role-Level: 4

This information is for internals only. Please do not share outside of the organization.

About SpringWorks Therapeutics

SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.

We developed and are commercializing the first and only FDA and EC approved medicine for adults with desmoid tumors and the first and only FDA and EC approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN).

At SpringWorks, we are committed to finding answers people with rare tumors need. We thrive in an atmosphere of passion and tenacity, fueled by the excitement of the possibilities science may unlock and driven to work with urgency because of the importance of our work. We value authenticity because diverse backgrounds, cultures, styles and abilities can only help us find the answers that people with rare tumors are looking for .

Your Role

The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. In some instances, the Director of GL may also take on the role of Team Lead for a therapeutic area (TA), overseeing Labeling Project Leads (LPLs) working on products within that TA and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising and Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and also driving forward global labeling initiatives.

Location Classification – Hybrid

This role will be required to work onsite 3 days a week (Tuesday - Thursday) or more depending on business needs. #LI-Hybrid

Key Accountabilities
  • Lead the development, review, approval, and implementation process for CCDSs, USPIs, EU SmPCs and labeling documents with cross-functional labeling teams. Prepare for senior management (LDB) review and approval.
  • Ensure all labeling is scientifically accurate and meets the needs of healthcare professionals and patients.
  • Provide tactical guidance to labeling teams regarding the labeling process, and regulatory requirements including application to product labeling content.
  • Disseminate labeling for implementation in the US/EU and support country regulatory affairs in implementation changes locally.
  • Support products in development by providing input into investigational brochures, development safety update reports and integrated evidence planning. In some cases, develop regulatory labeling strategy and content for products in development (i.e., target product label) with subject matter experts.
  • Maintain expertise regarding key labeling requirements worldwide and stay updated with FDA/EMA labeling guidelines and regulations.
  • Participate in labeling negotiations with agencies resulting in product approvals or labeling updates.
  • In collaboration with department head, develop and periodically review labeling policies and standards. Provide guidance, and in some cases, drive process improvement initiatives.
  • Support audits and CAPA resolutions.
  • Represent labeling on cross-functional leadership programs and advisory boards.
Minimum Qualifications
  • Bachelor’s degree in science or health-related discipline
  • 8+ years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs Labeling experience
  • Deep knowledge and application of labeling requirements in the US/EU
  • Experience managing labeling personnel and/or teams
Preferred Qualifications
  • Advanced degree (PhD, MD, MS, PharmD, MBA)
  • Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project), SharePoint and regulatory systems (e.g., EDMS)
  • Meticulous in reviewing regulatory documents for accuracy, consistency, and compliance
  • Excellent written and oral communication skills
  • Knowledge and application of labeling requirements in global countries including Japan and China
  • Knowledge of global drug-development and life-cycle management regulations
SpringWorks Leadership Principles
  • Change Steward - Recognize that change is essential; set goals that align to the Company’s strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
  • Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
  • Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
  • Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
Compensation & Benefits

The expected salary range for this position is $ 182,100 - 273,100 . Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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