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$95

How much do regulatory labeling jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for regulatory labeling in the United States is $30.53, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $39.18 per hour, depending on experience, location, and employer.

What is the difference between Regulatory Labeling vs Regulatory Documentation?

AspectRegulatory LabelingRegulatory Documentation
PurposeEnsures product labels meet regulatory standards and communicate necessary information to consumers and authorities.Prepares comprehensive reports, submissions, and records required for regulatory approval and compliance.
Work EnvironmentPrimarily office-based, collaborating with marketing, legal, and regulatory teams.Office and laboratory settings, often involving detailed technical writing and data compilation.
Required CredentialsTypically requires a degree in life sciences, regulatory affairs, or related fields; certifications like RAC are common.Similar credentials, often with advanced degrees or certifications in regulatory affairs or quality assurance.

While both roles focus on compliance, Regulatory Labeling concentrates on product labels and packaging, ensuring they meet legal standards. Regulatory Documentation involves creating detailed reports and submissions for regulatory approval. Both roles require similar qualifications and often work together to ensure product compliance throughout the development and marketing process.

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

To thrive as a Regulatory Labeling Specialist, you need a strong understanding of regulatory requirements, scientific knowledge, and experience with labeling guidelines, often supported by a life sciences degree. Familiarity with regulatory submission systems (such as FDA’s SPL), document management tools, and relevant certifications like RAC are typically required. Attention to detail, effective communication, and project management skills help ensure accuracy and collaboration across teams. These competencies are critical to producing compliant, clear, and timely product labeling that meets global regulatory standards.

What are some common challenges faced in a Regulatory Labeling role, and how can they be managed?

Professionals in Regulatory Labeling often encounter challenges such as keeping up with constantly changing global regulations, coordinating input from multiple departments, and ensuring labeling accuracy across different markets. Managing these challenges typically involves maintaining strong communication with regulatory affairs, legal, and product development teams, as well as staying updated through regulatory databases and ongoing training. Leveraging project management tools and establishing clear review processes can also help ensure labeling compliance and timely submissions.

What is regulatory labeling?

Regulatory labeling refers to the process of creating, reviewing, and maintaining product labels to ensure they comply with all relevant laws and regulations set by government authorities. This is especially important in industries like pharmaceuticals, food, and chemicals, where product labels must accurately reflect usage instructions, safety information, and legal requirements. Regulatory labeling professionals work closely with regulatory agencies and internal teams to make sure that all product information is truthful, clear, and up to date. Failure to comply with labeling regulations can result in fines, product recalls, or legal action.
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Regulatory Labeling jobs near you
Associate Director, Global Labeling Lead

Associate Director, Global Labeling Lead

Biogen

Cambridge, MA • On-site

$160K - $220K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago

Biogen rating

9.2

Company rating: 9.2 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

3rd of 71 rated pharmaceutical

Job description

About This Role
The purpose of the Global Labeling group is to drive Biogen's regulatory labeling strategy and ensure that labeling documents are of high quality and compliant for the safe and effective use of our products globally.
As a Global Labeling Associate Director, you would be responsible for developing the labeling strategy, leading the development and update of core, EU and US labeling documents and for overseeing implementation at a regional and local level. In this role, you may be responsible for overseeing the strategy for other products within your Therapeutic Area.
What You'll Do
  • Lead timely creation or management of regulatory compliant, competitive and up to date core, EU and US labeling documents throughout the product lifecycle including the Target Label Profile, Core Data Sheet, EU SmPC and USPI
  • Lead the cross functional product Labeling Team to reach consensus on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
  • Critically assess the data and propose the labeling strategy to be followed in core, EU and US labeling documents, ensuring alignment with global, regional and local regulatory strategies
  • Oversee distribution and tracking of Core Data Sheet updates for assigned products, ensuring compliance is maintained within the Electronic Document Management System and the Regulatory Tracking System
  • Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, influence the clinical development plan
  • Develop and implement strategy for global, EU and US labeling content
  • Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team
  • Partner with key stakeholders to ensure product labeling is the most current, accurate, relevant and competitive to inform prescribers and patients

Who You Are
You will have a passion for strategic regulatory labeling and will be enthusiastic to aid in the evolution of a new labeling department in a growing company. You will have a strong scientific grounding, an excellent eye for detail and a demonstrated understanding of the importance of labeling governance and compliance.
Required Skills
  • Bachelor's degree in a scientific or medically related discipline
  • 6+ years pharmaceutical/ biotechnology industry regulatory experience, including global, EU and US regulatory labeling
  • Advanced knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development
  • Experience in interpretation of global, EU and US regulations, guidelines, policy statements, etc.
  • Proven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts
  • Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts
  • Well organized, detail oriented, highly effective written and oral communication skills

Job Level: Management
Additional Information
The base compensation range for this role is: $160,000.00-$220,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation

Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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About Biogen

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At Biogen, our mission is clear - we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Together, our employees create, commercialize, and manufacture transformative therapies for our patient population.

Industry

Scientific research and development services

Company size

5,001 - 10,000 Employees

Headquarters location

Cambridge, MA, US

Year founded

1978

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