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Regulatory Affairs Labeling Associate Jobs (NOW HIRING)

SCHWAN'S

Regulatory Affairs Specialist

La Palma, CA

$75K - $99K/yr

Develop, approve, and maintain product labeling in compliance with regulatory standards Review ... affairs, labeling, and nutrition compliance Korean speaking/bilingual preferred Self-motivated ...

Schwans

Regulatory Affairs Specialist

Marshall, MN · On-site

$75K - $99K/yr

What You Will Do: • Develop, approve, and maintain product labeling in compliance with regulatory ... affairs, labeling, and nutrition compliance • Korean speaking/bilingual preferred • Self ...

RXinsider LTD.

Reviews and approves Marketing/Sales literature and labeling. * Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections. * Develops and presents ...

Boehringer Ingelheim GmbH

$36K - $49K/yr

Postdoctoral Regulatory Affairs Fellow - Product Labeling Content Description The Regulatory Affairs Labeling Content Fellowship is designed to provide pharmacists with exposure to regulatory ...

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How much do regulatory affairs labeling associate jobs pay per hour?

As of Sep 12, 2026, the average hourly pay for regulatory affairs labeling associate in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What does a regulatory affairs labeling associate do?

A Regulatory Affairs Labeling Associate is responsible for ensuring that product labels, packaging, and associated documentation meet all regulatory requirements set by government agencies and industry standards. They collaborate with cross-functional teams to develop and review labeling content for accuracy, compliance, and clarity. Their work is critical in the pharmaceutical, medical device, and biotechnology industries, where proper labeling ensures safety and transparency for consumers and regulators. Additionally, they help manage submissions and updates to regulatory authorities and stay informed on changing regulations.

What are the key skills and qualifications needed to thrive as a regulatory affairs labeling associate?

To thrive as a Regulatory Affairs Labeling Associate, you need a solid understanding of regulatory guidelines, labeling requirements, and a background in life sciences or pharmacy. Familiarity with regulatory submission systems, document management tools, and labeling software is typically required, along with knowledge of FDA and global regulations. Strong attention to detail, organizational skills, and effective cross-functional communication help you excel in managing complex documentation and timelines. These skills ensure accurate, compliant labeling that supports product approvals and ongoing regulatory compliance.

What are the main challenges a regulatory affairs labeling associate might encounter when working with global product labels?

A Regulatory Affairs Labeling Associate often faces the challenge of ensuring that product labels meet the diverse and evolving regulatory requirements of multiple countries. This involves closely monitoring updates from various health authorities, interpreting complex regulations, and coordinating with cross-functional teams such as R&D, marketing, and legal. Navigating language translations, local cultural nuances, and tight submission timelines can add further complexity. Strong organizational and communication skills are essential to manage these challenges effectively and maintain compliance.

What cities are hiring for Regulatory Affairs Labeling Associate jobs?

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Infographic showing various Regulatory Affairs Labeling Associate job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 68% Full Time, 28% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Director, Global Labeling - Regulatory Affairs

Billerica, MA • On-site

Merck Group
See more jobs at Merck Groupexternal

$159K - $210K/yr

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Key responsibilities

  • Lead the development, review, approval, and implementation of labeling documents such as CCDSs, USPI, and EU SmPCs.

  • Ensure all labeling is scientifically accurate and meets the needs of healthcare professionals and patients.

  • Provide guidance on regulatory labeling requirements, participate in labeling negotiations, and support global labeling initiatives.

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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