Job Title
Associate Director, Global Labeling Product Leader
Company
Johnson & Johnson
Locations
Horsham, Pennsylvania, USA
Raritan, New Jersey, USA
Titusville, New Jersey, USA
Note: This role is hybrid and can be based in any of these locations.
Work Pattern
Hybrid Work
Job Category
Senior Manager, Regulatory Affairs (P8)
Job Function
Regulatory Affairs Group
Sub Function
Regulatory Affairs
Job Posting Details
Date Posted: August 28, 2025
Requisition Number: R-029419
Application Deadline: September 11, 2025 (may be extended)
Apply at: www.careers.jnj.com
Company Overview
Johnson & Johnson believes health is everything. Their strength in healthcare innovation aims to develop smarter, less invasive, and personalized treatments to profoundly impact health worldwide. Their Innovative Medicine division focuses on developing medicines informed by patient insights.
Learn more:
Role Summary
The Associate Director, Global Labeling Product Leader will lead the global labeling strategy for pharmaceutical products. This role partners with cross-functional teams, including Global Regulatory Leads and other stakeholders, to ensure alignment between labeling strategies and global regulatory and product plans.
Key Responsibilities
Develop and drive global labeling strategies, considering competitor landscapes and therapeutic area trends.
Lead collaboration with Global Regulatory Leads and functional partners (clinical, safety, market access, commercial, medical affairs) to align labeling with global strategies.
Lead target labeling development and provide input on clinical study protocols, endpoints, and Patient-Reported Outcomes (PROs).
Provide strategic labeling advice for local markets.
Analyze competitor labeling and regulatory guidance to inform labeling strategy, including risk assessment and mitigation.
Lead Health Authority (HA) labeling strategy discussions and contingency planning.
Lead development, revision, review, and maintenance of target and primary labeling documents (e.g., Company Core Data Sheet (CCDS), United States Package Insert (USPI), European Union Product Information (EUPI), and derived documents).
Lead cross-functional Labeling Working Groups (LWGs) and strategic discussions.
Represent global labeling in regulatory and cross-functional teams.
Present labeling plans in governance meetings (e.g., Labeling Committee) for endorsement.
Provide guidance on labeling content, processes, timelines, and scientific integrity.
Coordinate resolution of labeling issues impacting primary/derived labeling or supporting documents.
Contribute to continuous improvement of labeling processes.
Support global labeling inspections and audits as applicable.
Collaborate with external partners as needed.
Qualifications / Requirements
Bachelor’s degree in a scientific discipline required; Advanced degree (Master’s, PhD, PharmD) preferred.
Minimum 8 years of professional experience.
At least 6 years of direct regulatory labeling content experience for pharmaceutical products.
Experience with target labeling development or New Molecular Entity (NME) submissions preferred.
Relevant pharmaceutical industry experience (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.).
Understanding of pharmaceutical drug development processes.
Strong communication skills for discussing scientific concepts.
Knowledge of global regulatory labeling guidelines and their application.
Experience leading project teams in a matrix environment.
Experience in continuous improvement initiatives.
Familiarity with document management systems.
Ability to prioritize and manage multiple products/projects preferred.
Exceptional verbal and written communication skills.
Strong organizational, negotiation, and partnering skills.
Ability to work independently.
Preferred: Ability to manage complex compounds from a labeling perspective.
Preferred: Ability to foster a collaborative, customer-focused, learning culture.
Compensation
Base Pay Range (U.S.): $137,000 to $235,750 (anticipated)
Eligible for annual performance bonuses based on individual and company performance.
Eligible for long-term incentive programs.
Benefits
Medical, dental, vision, life insurance
Short- and long-term disability
Business accident insurance, group legal insurance
Retirement plans: pension and 401(k) savings plan
Paid time off:
Vacation: up to 120 hours/year
Sick time: up to 40 hours/year (56 hours/year for Washington State residents)
Holidays (including floating holidays): up to 13 days/year
Work, Personal and Family Time: up to 40 hours/year
Parental Leave: 480 hours within 1 year of birth/adoption/foster care
Condolence Leave: 30 days (immediate family), 5 days (extended family)
Caregiver Leave: 10 days
Volunteer Leave: 4 days
Military Spouse Time-Off: 80 hours
More info: Employee Benefits
Equal Opportunity Employer Statement
Johnson & Johnson provides equal employment opportunities to all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other legally protected characteristics.
The company actively seeks candidates who are protected veterans and individuals with disabilities under VEVRAA and Section 503 of the Rehabilitation Act.
Accommodation Statement
Johnson & Johnson is committed to inclusive hiring. Applicants with disabilities needing accommodation can contact:
Email: ra-employeehealthsup@its.jnj.com
Or contact AskGS for accommodation resources.
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