Global Labeling Strategy Lead, Associate Director

Scorpion Therapeutics; New Jersey; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine R&D is seeking an Associate Director, Global Labeling Product Leader to guide worldwide labeling strategies for pharmaceutical products. You will collaborate with regulatory, clinical, safety, and commercial teams to shape target and primary labeling and align with global guidelines.

You will lead labeling development for NMEs, manage content across regions, represent labeling in governance, and negotiate with health authorities, while supporting

Qualifications

• Bachelor's degree in a scientific discipline with advanced degree preferred.
• At least 8 years of professional experience with 6+ years in regulatory labeling.
• Familiarity with drug development and worldwide regulatory standards.
• Experience with target labeling for NMEs and document management systems.

Responsibilities

• Developing target and primary labeling in collaboration with regulatory, clinical, safety, and commercial teams, and ensuring alignment with global regulatory guidelines.
• Leading labeling development for new molecular entities, managing labeling content across regions, and representing labeling in cross-functional governance.
• Strategic health authority negotiations, preparing contingency plans, and supporting inspections.

Skills

Regulatory labeling

Regulatory compliance

Strategic thinking

Effective communication

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

Document management systems

Job description

Johnson & Johnson's Innovative Medicine R&D is seeking an Associate Director, Global Labeling Product Leader to guide worldwide labeling strategies for pharmaceutical products. You will collaborate with regulatory, clinical, safety, and commercial teams to shape target and primary labeling and align with global guidelines.

You will lead labeling development for NMEs, manage content across regions, represent labeling in governance, and negotiate with health authorities, while supporting