Manager, Global Labeling Product Leader

4 years

$115,000 – $197,800

Titusville

10 Sept. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧪 Position Title:

Manager, Global Labeling Product Leader

🏢 Company:

Johnson & Johnson Innovative Medicine
🌐 www.jnj.com

📍 Location (Hybrid Eligible):

Raritan, NJ
Titusville, NJ
Horsham, PA

📅 Job Details:

Function: Regulatory Affairs
Sub-function: Regulatory Affairs
Job Category: Manager, Regulatory Affairs (P7)
Requisition Number: R-020573
Work Pattern: Hybrid
Date Posted: September 5, 2025
Anticipated Posting Close Date: September 20, 2025
(May be extended based on application volume)

🔍 About the Role:

The Manager, Global Labeling Product Leader plays a strategic and operational role in leading the development, revision, and maintenance of global regulatory labeling documents. You will ensure high-quality, compliant labeling aligned with regulatory requirements and contribute to continuous improvement of the labeling process.

🎯 Key Responsibilities:

🗂️ Labeling Development & Maintenance

Lead the preparation and updates of:
- Company Core Data Sheet (CCDS)
- United States Package Insert (USPI)
- EU Product Information (EUPI)
- Derived documents and patient labeling
Ensure labeling compliance, scientific accuracy, and alignment across geographies

🤝 Strategic & Cross-functional Collaboration

Collaborate with cross-functional teams to resolve labeling-related issues
Provide guidance and recommendations on labeling timelines, processes, and strategy
Ensure consistency and alignment with regulatory strategies globally

🧠 Labeling Strategy & Competitive Intelligence

Participate in shaping the global labeling strategy
Understand competitor labeling trends and development pipelines
Support creation of target labeling and regulatory dossiers

🔄 Continuous Improvement

Identify and implement enhancements in the end-to-end labeling process
Participate in process improvement initiatives across Regulatory Affairs

🎓 Qualifications:

✅ Required:

Bachelor’s degree in a scientific discipline
4+ years of experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, PV)
Strong understanding of drug development and scientific communications
Familiarity with labeling regulations and global regulatory guidelines
Experience leading project teams in a matrixed environment
Demonstrated ability to:
- Manage multiple products/projects
- Work independently
- Prioritize effectively
- Partner across functions
Excellent verbal and written communication skills
Proficiency in document management systems

⭐ Preferred:

Advanced degree (PhD, PharmD, Master’s)
3+ years of experience in Regulatory Affairs labeling
Experience in continuous improvement projects
Proven ability to drive collaborative and learning cultures

💰 Compensation & Benefits:

💵 Base Salary Range (U.S. Locations):

$115,000 – $197,800

💼 Incentives & Bonuses:

Eligible for annual performance bonus
Eligible to participate in long-term incentive programs

🎁 Employee Benefits (U.S.):

Medical, dental, vision insurance
Life and accident insurance
Short- and long-term disability
Group legal insurance
Pension and 401(k) plans

🕒 Time-Off Benefits:

Vacation: Up to 120 hours/year
Sick Time:
- 40 hours/year (56 hours for WA residents)
Holiday Pay: Up to 13 days/year (includes floating holidays)
Work, Personal & Family Time: Up to 40 hours/year

🔗 Explore Full Benefits

⚖️ Equal Opportunity Statement:

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to:

Race, color, religion, sex
Sexual orientation, gender identity
Age, national origin
Disability or veteran status
Or other protected characteristics

♿ Accommodations:

If you are an individual with a disability and need accommodation during the hiring process, please contact:
📧 ra-employeehealthsup@its.jnj.com
Or contact AskGS for more information.

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Manager, Global Labeling Product Leader

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