Global Labeling Product Leader – Regulatory Affairs

Johnson & Johnson Co.

Belgique

Hybrid

EUR 82,000 - 141,000

Full time

13 days ago

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Benefits offered by this job

Annual bonus
Vacation days
Parental leave
Well-being reimbursement

Job summary

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader to base in Beerse, Belgium or Warsaw, Poland. The role oversees strategic labeling development across product lifecycle, ensuring high‑quality, compliant labeling from CCDS to USPI and EU Product Information.

You will drive global labeling strategy, collaborate with Regulatory Affairs, and lead teams in a matrix environment while prioritizing multiple programs and maintaining scientific integrity.

Qualifications

  • Bachelor’s degree in a scientific field required.
  • 4+ years of relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) required.
  • 3+ years of Regulatory Affairs with labeling experience preferred.
  • Understanding of pharmaceutical drug development required.
  • Experience communicating scientific concepts.
  • Knowledge of worldwide regulatory labeling guidelines.

Responsibilities

  • Lead the development, revision, review, agreement and maintenance of primary labeling (CCDS, USPI, patient labeling, EU Product Information) and derived labeling documents for assigned compounds.
  • Provide advice on labeling content, processes and timelines; coordinate resolution of labeling issues with potential impact on labeling and documentation.
  • Contribute to global labeling strategy and stay informed on competitor labeling plans and regulatory trends.
  • Support continuous improvement of end-to-end labeling processes.

Skills

Analytical reasoning
Business writing
Coaching
Regulatory compliance
Regulatory development
Strategic thinking
Risk assessments
Public policies
Product licensing
Regulatory affairs management
Legal support
Industry analysis
Technical credibility

Education

Bachelor’s degree in a scientific discipline
Advanced degree (MS, PhD, MD or PharmD) preferred

Tools

Document management systems

Job description

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader to base in Beerse, Belgium or Warsaw, Poland. The role oversees strategic labeling development across product lifecycle, ensuring high‑quality, compliant labeling from CCDS to USPI and EU Product Information.

You will drive global labeling strategy, collaborate with Regulatory Affairs, and lead teams in a matrix environment while prioritizing multiple programs and maintaining scientific integrity.

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