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Regulatory Labeling Jobs in California (NOW HIRING)

CYNET SYSTEMS

Regulatory Specialist Sr

Santa Clara, CA · On-site

$48 - $53/hr

Experience developing regulatory labeling strategies and leading complex post-approval labeling initiatives. * Demonstrated experience managing cross-functional projects and successfully delivering ...

Abbott

Regulatory Specialist Sr

Lakeside, CA · On-site

This role will lead complex addendum and supplemental labeling initiatives, partnering with Regulatory Affairs, Quality, Supply Chain, Packaging, Manufacturing, and international affiliates to ensure ...

Collabera

Label Designer

Temecula, CA

Creates, updates, and maintains labeling formats produced with in-house production printing systems that are in compliance with domestic and international regulatory labeling requirements, Health ...

CYNET SYSTEMS

Labeling Specialist

Cupertino, CA · On-site

$62 - $67/hr

Knowledge of domestic and international medical device regulatory requirements for product labeling and unique device identification (e.g. 21 CFR 801 and EU MDR). * Knowledge of quality management ...

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Regulatory Labeling information

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.
What are the most commonly searched types of Regulatory Labeling jobs in California? The most popular types of Regulatory Labeling jobs in California are:
What are popular job titles related to Regulatory Labeling jobs in California? For Regulatory Labeling jobs in California, the most frequently searched job titles are:
What job categories do people searching Regulatory Labeling jobs in California look for? The top searched job categories for Regulatory Labeling jobs in California are:
What cities in California are hiring for Regulatory Labeling jobs? Cities in California with the most Regulatory Labeling job openings:
Regulatory Labeling jobs near you
Infographic showing various Regulatory Labeling job openings in California as of July 2026, with employment types broken down into 73% Full Time, 9% Part Time, and 18% Contract. Highlights an 100% In-person job distribution.

Director, Regulatory Affairs (Labeling)

Arrowhead Pharmaceuticals

Pasadena, CA • On-site

$163K - $216K/yr

Full-time

Re-posted 8 days ago

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross-functional development and execution of global regulatory labeling strategy. This individual will manage regulatory labeling through all phases of development and post-approval (end-to-end) ensuring that the latest requirements and standards are met.
The ideal candidate will have experience collaborating with product and clinical development, medical, market access, and commercial stakeholders to generate phase and time-appropriate target product profile and labeling drafts, has successfully negotiated with health authorities, and global regulatory experience.
Responsibilities
  • Collaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetings.
  • Manage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements.
  • Maintain expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles.
  • Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
  • Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
  • Liaise with cross functional members and stakeholders to obtain input pertaining to labeling including resolution of key regulatory issues and labeling changes .
  • Partner with Clinical Regulatory and cross-functional teams to support labeling supplements and updates, and health authority interactions related to labeling
  • Ensure the dissemination of approved labeling documents and supporting documentation.
  • Maintain controlled records for all labeling changes and communicate labeling updates to stakeholders at the time of implementation.
  • Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
  • Participate in any relevant continuous improvement efforts for the end-to-end labeling process.
  • Monitor global regulatory environment and assess impact of changes on business and product labeling activities.
  • Facilitate policy development and updates with internal stakeholders.

Requirements
  • Bachelor's degree in life sciences, computer science, or related science discipline
  • Minimum 8+ in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas.
  • Knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
  • Experience leading cross-functional meetings and facilitating strategic discussions, such as negotiating with internal stakeholders and regulatory authorities on complex labeling issues.
  • Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistencies.
  • Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools)
  • Ability to maintain highest degree of professionalism, integrity and diplomacy

Preferred
  • Experience with regulatory information management systems (e.g., Veeva RIM, Registrations).
  • Knowledgeable in emerging technologies, including AI applications in regulatory operations.
  • Experience supporting global inspection readiness.

California pay range
$210,000-$230,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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