Instagram
youtube
Facebook

Senior Manager, Global Labeling Product Leader

6-8 years
$137,000 to $235,750
10 April 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title:
Senior Manager, Global Labeling Product Leader (2 Positions)

Function:
Regulatory Affairs Group

Sub Function:
Regulatory Affairs

Category:
Senior Manager, Regulatory Affairs (P8)

Location:
Raritan / Titusville / Horsham / United States of America

Date Posted:
April 25, 2025

Requisition Number:
R-007626

Work Pattern:
Hybrid Work

Closing Date:
May 03, 2025 (May be extended)

Description:
Johnson & Johnson is recruiting for a Senior Manager, Global Labeling Product Leader to join their team in Raritan, NJ; Titusville, NJ; or Horsham, PA. This role will lead global labeling activities, develop labeling content (CCDS, USPI, EUPI), and manage regulatory compliance for new and modified products worldwide. The Senior Manager will work to ensure high-quality labeling documents and contribute to the global labeling strategy.

Essential Job Functions:

  • Lead development and maintenance of primary labeling documents (CCDS, USPI, EUPI).

  • Advise and guide teams on labeling content, timelines, and regulatory compliance.

  • Collaborate with cross-functional teams and external partners to resolve labeling issues.

  • Implement global labeling strategies and contribute to continuous improvement of the labeling process.

  • Ensure compliance with worldwide regulatory guidelines for labeling.

Qualifications:

  • Minimum of 8 years of professional experience required.

  • At least 6 years of regulatory labeling content experience for pharmaceutical products.

  • Strong understanding of pharmaceutical drug development.

  • Excellent verbal and written communication skills.

  • Experience leading teams and managing multiple projects.

  • Bachelor's degree in a scientific discipline required (Advanced degree preferred).

Salary Range:

  • $137,000 to $235,750 (Base pay range for U.S. locations)

Additional Information:

  • Eligible for annual performance bonus.

  • Comprehensive benefits package, including medical, dental, vision, and 401(k).

  • Vacation, sick time, holiday pay, and family time off.

EEO Statement:
Johnson & Johnson is an Equal Opportunity Employer.