Senior Global Regulatory Labeling Product Leader

Biopharma Careers; Raritan (NJ); Hybrid; USD 137,000 - 236,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days/year

401(k) plan and pension

Job summary

Johnson & Johnson Innovative Medicine is seeking an Associate Director, Regulatory Affairs Labeling Product Leader for a hybrid role based in Raritan, NJ, or Titusville, NJ, or Horsham, PA. You will drive the global labeling strategy and lead a cross-functional Labeling Working Group to align with product strategy.

The role requires 8+ years of regulatory labeling experience, strong communication, and project leadership in a matrix environment; experience with target labeling development and HA

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• 8+ years of professional work experience; 6+ years in regulatory labeling content.
• Experience leading labeling for regulatory submissions and NME filings preferred.
• Strong communication, organizational, and partnering skills.
• Experience in a matrix environment and cross-functional teams.

Responsibilities

• Drive the global labeling strategy across product life cycles.
• Lead Target and Primary labeling development and HA discussions.
• Collaborate with GRLs and cross-functional partners to align labeling with strategy.
• Provide strategic labeling advice for local labeling in major markets.
• Lead Labeling Working Group and governance presentations.

Skills

Global labeling strategy

Cross-functional leadership

Regulatory affairs

Excellent communication

Project management

Negotiation

Matrix leadership

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Tools

Document management systems

Job description

Johnson & Johnson Innovative Medicine is seeking an Associate Director, Regulatory Affairs Labeling Product Leader for a hybrid role based in Raritan, NJ, or Titusville, NJ, or Horsham, PA. You will drive the global labeling strategy and lead a cross-functional Labeling Working Group to align with product strategy.

The role requires 8+ years of regulatory labeling experience, strong communication, and project leadership in a matrix environment; experience with target labeling development and HA