Global Labeling Product Leader - Regulatory Affairs

Biopharma Careers

Raritan (NJ)

Hybrid

USD 117,000 - 201,000

Full time

8 days ago

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Job summary

Johnson & Johnson in the United States is seeking a Manager, Global Labeling Product Leader based in Raritan, NJ; Titusville, NJ; or Horsham, PA. You will lead development and maintenance of CCDS, USPI and labeling for multiple products, ensuring scientific accuracy and regulatory compliance.

You will guide labeling strategy across regions, coordinate with regulatory, scientific, and medical teams, and drive process improvements in a global, matrix environment.

Qualifications

  • Bachelor's degree in a scientific discipline is required.
  • Advanced degree (MS, PhD, MD or PharmD) preferred.
  • Minimum 4 years of pharmaceutical industry experience.
  • Minimum 3 years in Regulatory Affairs with labeling experience preferred.
  • Knowledge of worldwide labeling guidelines and regulatory development.
  • Experience leading cross-functional teams in a matrix environment.

Responsibilities

  • Lead development and maintenance of CCDS, USPI, and labeling for assigned products.
  • Advise on labeling content, timelines, and scientific integrity.
  • Coordinate resolution of labeling issues affecting primary/derived labeling.
  • Contribute to global labeling strategy and continuous process improvements.

Skills

Regulatory Affairs
Labeling regulations
Project leadership
Communication

Education

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

Job description

Johnson & Johnson in the United States is seeking a Manager, Global Labeling Product Leader based in Raritan, NJ; Titusville, NJ; or Horsham, PA. You will lead development and maintenance of CCDS, USPI and labeling for multiple products, ensuring scientific accuracy and regulatory compliance.

You will guide labeling strategy across regions, coordinate with regulatory, scientific, and medical teams, and drive process improvements in a global, matrix environment.

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