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Regulatory Labeling Jobs (NOW HIRING)

ImmunityBio

Director, Global Labeling Regulatory

Summit, NJ · On-site

$159K - $210K/yr

Position Summary The Director, Global Labeling Regulatory will orchestrate the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle. This ...

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Regulatory Labeling information

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$12

$30

$95

How much do regulatory labeling jobs pay per hour?

As of Jul 14, 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 a regulatory labeling specialist?

A regulatory labeling specialist is a professional responsible for developing, reviewing, and maintaining product labels to ensure compliance with industry regulations and standards. They often work with regulatory agencies, use labeling software, and stay updated on legal requirements to ensure accurate and compliant product information.

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.

What is regulatory labelling?

Regulatory labeling involves creating and maintaining product labels that comply with government regulations and industry standards. It ensures that product information such as safety warnings, ingredients, and usage instructions meet legal requirements, often requiring attention to detail and knowledge of relevant regulations. Regulatory labelers may work with documentation tools and certification processes to ensure compliance.

Which is better, RA or QA?

Regulatory Affairs (RA) and Quality Assurance (QA) are distinct roles in the compliance and quality management of products. RA focuses on ensuring products meet regulatory requirements and preparing documentation for approval, while QA emphasizes maintaining product quality through testing and process controls. Both roles are essential, and their importance depends on the company's priorities and product lifecycle stage.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can earn six-figure salaries. These roles often require extensive experience, advanced certifications, and leadership skills in managing compliance strategies across industries like pharmaceuticals and medical devices.
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Regulatory Labeling jobs near you
Infographic showing various Regulatory Labeling job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 71% Full Time, 23% Part Time, 1% Temporary, 3% Contract, and 1% Nights. Highlights an 97% Physical, and 3% Remote job distribution, with an average salary of $63,493 per year, or $30.5 per hour.
Director/Sr. Director Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory

Director/Sr. Director Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory

Agios Pharmaceuticals Inc

Cambridge, MA

$163K - $215K/yr

Full-time

Re-posted 8 days ago

Job description

Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory

Who we are:

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit www.agios.com and follow Agios on LinkedIn and X.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Director/Sr Director, Regulatory Labeling Strategy, Advertising, and Promotion to provide expert, strategic regulatory guidance and oversight for all labeling activities and promotional and non-promotional communications to ensure compliance with applicable regulations, including FDA requirements. This individual will be responsible for development of global labeling documents (e.g. CCDS, regional product information, and patient leaflets) and serve on the Agios Review Committee as the Regulatory Reviewer responsible for the review and approval of promotional and non-promotional materials across the Agios portfolio. This individual will partner cross-functionally with Legal, Commercial, Corporate Communications, and Medical, as well as other cross-functional stakeholders within the Research and Development organization, to enable compliant, effective messaging, development of labeling, and promotional and non-promotional materials to supports business objectives while protecting the company's integrity and reputation.

What you will do:

  • Provide global regulatory labeling expertise and ensure adherence to global regulations in support of the development, review, and approval of labeling documents.
  • Manage the creation and/or maintenance of global labeling strategy and documents (e.g. CCDS, regional product information, and patient leaflets).
  • Collaborate closely with Commercial, Clinical, Legal, and Medical, as well as other cross-functional stakeholders within research and development, to shape compliant messaging strategies and effective labeling documents
  • Lead regulatory strategy for advertising and promotional materials across all stages (pre-approval, launch, and lifecycle) by serving on the Agios Review Committee (ARC) as the Regulatory Reviewer responsible for the review and approval of promotional and non-promotional materials across the Agios portfolio
  • Serve as the internal subject matter expert on FDA advertising and promotion regulations, including OPDP expectations and evolving enforcement trends
  • Ensure timely and accurate FDA 2253 submissions of US promotional materials.
  • Interface with regulatory authorities (e.g., OPDP) as needed, including managing inquiries or enforcement responses
  • Provide risk-based guidance that balances compliance with business impact and speed
  • Ensure all materials (HCP, patient, digital, payer, investor-facing where applicable) meet regulatory requirements
  • Guide teams on appropriate claim substantiation, fair balance, and risk disclosure
  • Regularly assess labeling updates to determine their impact on previously approved materials and identify when revisions are required, ensuring changes are reflected in current promotional and advertising materials.
  • Influence brand planning, campaign development, and launch readiness
  • Act as a trusted advisor to senior leadership on promotional risk and opportunity
  • Develop and maintain internal policies, SOPs, and guidance related to labeling and promotional practices
  • Drive continuous improvement of review processes to enhance speed, clarity, and effectiveness
  • Implement scalable systems appropriate for a growing organization
  • Lead /oversee training programs for cross-functional teams on labeling regulatory requirements and best practices
  • Foster a culture of compliant innovation and accountability

What you bring:

  • Bachelor's degree required; advanced degree (PhD, PharmD, JD, or MS) preferred
  • Director:
    • 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry
    • 7+ years experience developing regulatory labeling documents (CCDS, local labels, patient leaflets).
    • 7+ years experience in Advertising & Promotion / OPDP compliance
  • Senior Director:
    • 15+ years of experience in Regulatory Affairs within the biopharmaceutical industry
    • 12+ years experience developing regulatory labeling documents (CCDS, local labels, patient leaflets).
    • 12+ years experience in Advertising & Promotion / OPDP compliance
  • Demonstrated experience leading Medical, Legal and Regulatory review processes
  • Strong knowledge of FDA regulations, guidance, and enforcement trends related to promotion
  • Proven ability to operate both strategically and tactically
  • Strong track record of cross-functional influence, external engagement, and operating effectively in a matrixed environment with cross-functional teams
  • Experience supporting late-stage assets and/or product launches preferred

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

  • Deliberate Development. Your professional growth as one of our top priorities.
  • Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.
  • Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
  • Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
    • The current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized and the current base salary range for this position at the Senior Director level is expected to be between $229,562 and $344,342 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
  • Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
  • Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
  • Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.

Employment Type: Full time

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