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Regulatory Labeling Associate Director 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 ...

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 labeling associate director jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for regulatory labeling associate director 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 does a regulatory labeling associate director do?

A Regulatory Labeling Associate Director is responsible for overseeing the creation, review, and maintenance of product labeling for pharmaceuticals, biologics, or medical devices to ensure compliance with global regulatory requirements. They collaborate with cross-functional teams, including regulatory affairs, clinical, and legal departments, to develop labeling that accurately reflects product safety and efficacy. This role also involves staying updated on regulatory changes, guiding labeling strategy, and interacting with health authorities during product submissions and approvals. Their work helps ensure that product information provided to healthcare professionals and patients is clear, accurate, and meets all legal standards.

What are the key skills and qualifications needed to thrive as a regulatory labeling associate director?

To thrive as a Regulatory Labeling Associate Director, you need deep expertise in regulatory affairs, drug labeling requirements, and global health authority guidelines, typically supported by a degree in life sciences or pharmacy. Proficiency with regulatory submission tools, document management systems, and familiarity with eCTD and labeling software is crucial. Exceptional attention to detail, leadership, and strong cross-functional communication skills distinguish top performers in this role. These skills ensure accurate, compliant product labeling and successful coordination with internal teams and regulatory agencies, which are vital for product approval and patient safety.

What are some common challenges faced by a regulatory labeling associate director when managing global product labeling across different regions?

A Regulatory Labeling Associate Director often encounters challenges such as navigating varying and frequently changing regulatory requirements across multiple countries, synchronizing updates to ensure global consistency, and coordinating cross-functional teams including regulatory, medical, and legal departments. Balancing tight timelines for product launches or updates while ensuring accuracy and compliance is also a key challenge. Effective communication and proactive planning are essential to address these complexities and maintain alignment with both internal stakeholders and health authorities.

What are popular job titles related to Regulatory Labeling Associate Director jobs?

For Regulatory Labeling Associate Director jobs, the most frequently searched job titles are:

Infographic showing various Regulatory Labeling Associate Director job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 67% Full Time, 29% 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 $63,493 per year, or $30.5 per hour.

Associate Director, Regulatory Affairs Labeling Product Leader

Raritan, NJ • On-site

Jj
See more jobs at Jjexternal

Full-time

Retirement, PTO

Re-posted 20 days ago

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Regulatory Affairs Labeling Product Leader. This position is a hybrid role and will be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

The Associate Director, Regulatory Affairs Labeling Product Leader will be responsible for the following:

  • Drive the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area, their development plans and status and knowledge of labeling aspects for labeling development and target labeling for new products.

  • Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products.

  • Lead target labeling development.

  • Collaborate with functional areas to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes (PROs), with a label-as-driver approach.

  • Provide strategic labeling advice for local labeling in major markets.

  • Analyze relevant competitor labeling, leverage labeling guidance and trends to develop labeling strategy and content, including risk and mitigation identification and assessment.

  • Lead Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content.

  • Lead the development, revision, review, agreement, and maintenance of target labeling, primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents) for assigned compounds.

  • Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions leading to development of target and primary labeling.

  • Represent global labeling in Global Regulatory teams and other cross-functional teams, as appropriate.

  • Present at governance meetings, such as Labeling Committee, to seek endorsement of labeling.

  • Provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents.

  • Contribute to the continuous improvement of the end-to-end labeling process.

  • Support global labeling inspections and audits for assigned products, as applicable

  • This role may collaborate with external partners.


Qualifications:

  • A minimum of a Bachelor's degree in a scientific discipline is required. Advanced degree (Master's PhD, PharmD) in a scientific discipline is preferred.

  • A minimum of 8 years of professional work experience is required.

  • A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.

  • Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.

  • Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.

  • An understanding of pharmaceutical drug development is required.

  • Experience in discussing and communicating scientific concepts is required.

  • Good understanding of worldwide regulatory guidelines and their application for guidance for labeling is required.

  • Experience leading project teams in a matrix environment is required.

  • Experience leading continuous improvement projects is required.

  • Experience working with document management systems is required.

  • Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.

  • Must have exceptional verbal and written communication skills.

  • Must have strong organizational, negotiation, and partnering skills.

  • Must have the ability to work independently.

  • The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.

  • The ability to drive a collaborative, customer-focused, learning culture is preferred.


Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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