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Regulatory Labeling Manager Jobs (NOW HIRING)

LanceSoft Inc

Labeling Specialist

Jersey City, NJ

... regulations and FDA guidance to the level of applying them effectively to all work output. Specific responsibilities include: Assisting labeling managers with overall labeling process of brand ...

Bakerly

Regulatory Compliance Specialist

Easton, PA · On-site

Managing internal and external label approval processes for multi-country compliance (US, Canada, Mexico). * Providing regulatory review for customer-specific programs (e.g., Walmart Bettergoods or ...

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How much do regulatory labeling manager jobs pay per hour?

As of Jun 30, 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 Scientist, Global Labeling Regulatory

NKW NantKwest Inc

Summit, NJ • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 days ago

Key responsibilities

  • Create and execute global labeling strategies from early clinical development through commercialization.

  • Ensure that all labeling content and artwork comply with international and local Health Authority regulations and implement updates as needed.

  • Act as the primary labeling representative on project teams, coordinating with cross-functional departments and managing the process of updating label content and artwork.

Job description

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.
Why ImmunityBio?
ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
Work with a collaborative team with the ability to work across different areas of the company.
Ability to join a growing company with professional development opportunities.

Position Summary

The Principal Scientist, Global Labeling will report to the Director, Global Labeling and be responsible forthe strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle. This expert will work with other cross-functional teams and SMEs to ensure that all labeling for investigational and marketed drugs meet the regulatory requirements of global health authorities.

Essential Functions

  • Create and execute global labeling strategies from early clinical development through commercialization.
  • Contribute to writing and maintaining key labeling documents, such as US Prescribing Information (USPI), and the EU Summary of Product Characteristics (SmPC).
  • Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP). This includes monitoring for regulatory changes and implementing updates.
  • Act as the primary labeling representative on various project teams, coordinating with departments like Clinical, Safety, Medical Affairs, Quality, Commercial, and Supply Chain.
  • Manage the process of updating label content and artwork for packaging and supplies, coordinating with manufacturing and third-party vendors.
  • Advise internal stakeholders on labeling content, processes, timelines, and potential risks, and present labeling strategies to senior leadership.
  • Lead or support negotiations with Regulatory Agencies regarding the content of product labels.
  • Create label technical specifications
  • Creation of labeling related change controls
  • Review and approve label proofs provided by internal and external labeling teams
  • Assist with the preparation of responses to Health Authority comments and questions pertaining to labeling issues.
  • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

  • Bachelor's degree in life sciences or related field with 10+ years' experience working on clinical and commercial labels for varied types of drug products in a global setting required; or
  • Master's degree in life sciences or related field with 8+ years' experience working on clinical and commercial labels for varied types of drug products in a global setting required.
  • Familiar with organizing responses to Health Authority requests required
  • Experience with Veeva Vault preferred

Knowledge, Skills, & Abilities

  • Expert in Global Health Authority Regulatory labeling requirements for both clinical and/or commercial stage products
  • Proficient in Electronic Document Management Systems
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Strong organizational skills, written and oral communication skills, and attention to detail.
  • Keen awareness of cultural sensitivities
  • Experience working in a complex and matrix environment
  • Excellent interpersonal skills

Working Environment / Physical Environment

  • This position works on site in Summit, NJ.
  • Regular work schedule is Monday-Friday, within standard business hours. Flexibility is available
  • A Principal Scientist may need to sit for long periods of time and use various computer programs.
  • This desk-based role involves the close study of scientific and regulatory documents.
  • They will work closely with scientific colleagues throughout the day, often on a project team basis.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

$168,000 (entry-level qualifications) to $184,400 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

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