Global Labeling Product Leader (Regulatory Affairs)

Johnson & Johnson Co.; Titusville (NJ); Vor Ort; USD 117.000 - 201.000; Vollzeit

Benefits dieser Stelle

Vacation benefits

Sick time

Holiday pay

Parental leave

Volunteer leave

Military leave

Zusammenfassung

Johnson & Johnson is seeking a Manager, Global Labeling Leader to guide strategic labeling development and lifecycle management. The role is based in New Jersey and supports cross-functional teams across regions.

You will lead CCDS, USPI, and EU labeling, coordinate labeling activities, and ensure high-quality, compliant documents while driving process improvements and regulatory alignment.

Qualifikationen

• Bachelor’s degree in a scientific discipline required; an advanced degree is preferred.
• Minimum 4 years in pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information or Pharmacovigilance).
• Minimum 3 years Regulatory Affairs with labeling experience preferred.
• Understanding of worldwide regulatory guidelines and labeling applications.
• Experience leading project teams in a matrix environment.
• Strong communication, organizational, negotiation, and partnering skills.

Aufgaben

• Lead development, revision, review, and maintenance of CCDS/USPI and labeling documents.
• Advise on labeling content, timelines, and scientific integrity; resolve labeling issues.
• Contribute to global labeling strategy and competitive landscape awareness.
• Support continuous improvement of end-to-end labeling processes.

Kenntnisse

Analytical reasoning

Business writing

Regulatory affairs management

Regulatory compliance

Strategic thinking

Technical credibility

Coaching

Ausbildung

Bachelor’s degree in a scientific discipline

MS/PhD/MD/PharmD preferred

Tools

Document management systems

Jobbeschreibung

Johnson & Johnson is seeking a Manager, Global Labeling Leader to guide strategic labeling development and lifecycle management. The role is based in New Jersey and supports cross-functional teams across regions.

You will lead CCDS, USPI, and EU labeling, coordinate labeling activities, and ensure high-quality, compliant documents while driving process improvements and regulatory alignment.