Global Labeling Product Leader — Regulatory Strategy

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Hybrid; EUR 82,000 - 141,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader to support labeling across Beerse, Belgium or Warsaw, Poland. The role leads primary and derived labeling, collaborates across regulatory functions, and drives labeling quality and strategy.

This position offers hybrid work options and international exposure. Required: strong regulatory labeling expertise, scientific background, and proven team leadership.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• An advanced degree (MS, PhD, MD or PharmD) is preferred.
• Minimum 4 years of relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance).
• Minimum 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent.
• Understanding of pharmaceutical drug development is required.
• Experience discussing and communicating scientific concepts is required.
• Basic understanding of worldwide regulatory guidelines for labeling is required.
• Experience leading project teams within a matrix environment; able to work with limited supervision.
• Demonstrated proactive approach and experience in continuous improvement; strong communication and collaboration.
• Experience working in document management systems.
• Ability to prioritize and manage multiple products and projects.
• Demonstrated customer-focused mindset and strategic thinking.

Responsibilities

• Lead development, revision, review, agreement, and maintenance of primary labeling (CCDS/USPI) and derived documents for assigned compounds.
• Provide advice on labeling content, processes, timelines, and scientific integrity.
• Coordinate resolution of labeling issues with potential impact on primary or derived labeling.
• Ensure high quality and compliant labeling documents.
• Contribute to global labeling strategy and understand competitors in therapeutic areas.
• Contribute to continuous improvement of the end-to-end labeling process.

Skills

Analytical reasoning

Coaching

Regulatory compliance

Regulatory development

Strategic thinking

Risk assessments

Public policies

Regulatory affairs management

Technical credibility

Process improvements

Legal support

Industry analysis

Education

Bachelor's degree in scientific discipline

Advanced degree (MS, PhD, MD or PharmD)

Tools

Document management systems

Job description

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader to support labeling across Beerse, Belgium or Warsaw, Poland. The role leads primary and derived labeling, collaborates across regulatory functions, and drives labeling quality and strategy.

This position offers hybrid work options and international exposure. Required: strong regulatory labeling expertise, scientific background, and proven team leadership.