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Regulatory Affairs Labeling Associate Jobs (NOW HIRING)

Revolution Medicines

Director, Regulatory Affairs Labeling

$153K - $202K/yr

Revolution Medicines is seeking a Director, Regulatory Affairs Labeling, who will drive cross-functional development and execution of global regulatory labeling strategy for pipeline, late stage, and ...

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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.

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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.

Global Regulatory Affairs (GRA) Labeling Associate

Swiftwater, PA • On-site

Artech Information System LLC
Recruiting and Staffing Services • 10K+ employees
Learn more about Artech Information System LLCexternal

Contractor

Re-posted 4 days ago

Key responsibilities

  • Ensure adherence to local and global labeling processes using appropriate tools and systems to maintain compliance with company and GMP standards.

  • Lead and write the United States Package Insert (USPI) for a specific product in preparation for a US BLA submission.

  • Participate in scientific, technical, and operational exchanges with cross-functional teams to ensure labeling documents are accurate and compliant.

Job description

Company Description

Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.

Job Description

This Global Regulatory Affairs (GRA) Labeling Associate position will ensure active adherence to the local and global labeling processes using the appropriate tools and systems to ensure harmonization and compliance with company and GMP standards and specifications. This Global Regulatory Affairs Labeling Associate role will have the specific duty to fully lead and write a United States Package Insert (USPI) for a particular assigned product in preparation for a US BLA submission.
This position will contribute to the Quality Enhancement Plan (QEP) through continuous and vigilant evaluation of labelling compliance via the Labelling Change Control process and the end to end labeling process flow. The position will do this by strictly following both local and global procedures. The Global Regulatory Affairs Labeling Associate will participate in scientific, technical and operational exchanges with Clinical Development, Pharmacovigilance, Medical Affairs, Marketing, Industrial Operations, Legal, Regulatory Affairs Franchise and Global Labeling as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with company standards, and meet company needs.
Key Accountability:
Enhance the scientific contribution of the GRA Labeling group and work in concentration with Clinical Development, Pharmacovigilance and Medical Affairs on-site and/or globally.
Represent GRA Labeling department on product and project teams by interfacing with other functions and leading particular projects and products through completion and/or licensure where appropriate.
Achieve consistency in labeling and Regulatory labeling process through regulatory standards, cross functional collaboration and interactions with health authorities where appropriate.
Contribute to the label control, format and design of packaging for leaflets, cartons and labels of specific products and coordinate implementation of labeling components in collaboration with Industrial Operations where appropriate.
Actively participate in regulatory aspects of internal project plans and ensure timelines are met and milestones are achieved.
Focus will be on the details of the scientific/medical documentation required to ensure accurate and complete label development, evaluations, reviews, and approvals. Need to contribute to productive yet challenging relationships with cross-functional areas to ensure integrity and quality of Regulatory output.
Skills:
4-8 years prior Regulatory Affairs or relevant industry experience.
Demonstrated experience with biopharmaceuticals and management capability
Business Certification and/or experience preferred.

Qualifications

Bachelor's degree in scientific field preferred.
Advanced degree preferred.

Additional Information

For more information, Please contact

Best Regards,
Akriti Gupta
(973) 967-3409
Morristown, NJ 07960


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About Artech

Sourced by ZipRecruiter

Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).

Industry

Recruiting and staffing services

Company size

10,000+ Employees

Headquarters location

Morristown, NJ, US

Year founded

1992

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