Global Labeling Strategy Lead

Biopharma Careers; Raritan (NJ); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year

Holiday pay and time-off

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Manager, Regulatory Affairs Labeling Product Leader. The role is hybrid and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

You will drive global labeling strategy, coordinate with GRLs, and lead cross-functional labeling efforts across programs. The position requires strong communication, project leadership, and expert knowledge of CCDS, USPI, and regional labeling requirements.

Qualifications

• Bachelor's degree in a scientific discipline required or equivalent.
• Advanced degree (Master’s/PhD/PharmD) preferred.
• 8+ years of professional work experience in related field.
• 6+ years of regulatory labeling content experience required.
• Experience leading labeling projects in a matrix environment preferred.

Responsibilities

• Lead global labeling strategy aligning with global regulatory goals.
• Collaborate with GRLs and cross-functional teams to ensure labeling strategy coherence.
• Lead target labeling development and cross-functional discussions.
• Provide labeling guidance for local markets and HA interactions.
• Develop and maintain CCDS, USPI, and patient labeling with quality and timelines.
• Represent labeling in governance meetings and drive continuous improvements.

Skills

Regulatory labeling

Leadership

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

Document management systems

Job description

Johnson & Johnson Innovative Medicine is seeking a Senior Manager, Regulatory Affairs Labeling Product Leader. The role is hybrid and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

You will drive global labeling strategy, coordinate with GRLs, and lead cross-functional labeling efforts across programs. The position requires strong communication, project leadership, and expert knowledge of CCDS, USPI, and regional labeling requirements.