Global Labeling Product Leader – Regulatory Affairs

6084-Janssen Research & Development, LLC Legal Entity; Raritan (NJ); Sur place; USD 117 000 - 201 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Vacation days

Sick leave

Parental leave

Résumé du poste

Johnson & Johnson in New Jersey is seeking a Manager, Global Labeling Product Leader to shape labeling strategy across products and regions. You will lead cross-functional teams to ensure compliant labeling and lifecycle management from CCDS to USPI.

The role requires a scientific degree, 4+ years in pharma regulatory affairs, and strong writing and project-management skills. The position offers a hybrid work arrangement and comprehensive benefits.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Advanced degree (MS, PhD, MD or PharmD) is preferred.
• A minimum of 4 years of relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required.
• A minimum of 3 years of Regulatory Affairs with experience in product labeling/labeling regulations is preferred.
• Strong communication of scientific concepts is required.
• Experience leading project teams in a matrix environment is required.

Responsabilités

• Leading the development, revision, review, agreement, and maintenance of primary labeling (CCDS, USPI) and derived labeling documents.
• Providing guidance on labeling content, processes, timelines, and scientific integrity.
• Coordinate resolution of labeling issues with impact on primary or derived labeling.
• Ensure high quality, compliant labeling documents.
• Contribute to the global labeling strategy and continuous improvement of end-to-end labeling processes.

Connaissances

Analytical reasoning

Business writing

Coaching

Regulatory affairs management

Regulatory compliance

Regulatory development

Regulatory environment

Risk assessments

Strategic thinking

Technical credibility

Formation

Bachelor’s degree in a scientific discipline

Advanced degree (MS, PhD, MD or PharmD) preferred

Outils

Document management systems

Description du poste

Johnson & Johnson in New Jersey is seeking a Manager, Global Labeling Product Leader to shape labeling strategy across products and regions. You will lead cross-functional teams to ensure compliant labeling and lifecycle management from CCDS to USPI.

The role requires a scientific degree, 4+ years in pharma regulatory affairs, and strong writing and project-management skills. The position offers a hybrid work arrangement and comprehensive benefits.