Global Labeling Strategy Lead – Regulatory Affairs

Scorpion Therapeutics; Raritan (NJ); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Manager, Regulatory Affairs Labeling Product Leader to develop and execute global labeling strategies for innovative medicines. You will lead target labeling development, align content with global regulatory requirements, and collaborate with clinical, safety, market access, and medical teams to ensure compliance and strategic alignment.

The role involves managing labeling content across multiple markets, guiding health authority discussions, and leading

Qualifications

• Bachelor’s in a scientific discipline; advanced degrees preferred.
• 8+ years of professional experience with at least 6 years in regulatory labeling for pharmaceuticals.
• Experience in Regulatory Affairs, Clinical, Medical Information, or Pharmacovigilance is required.
• Strong understanding of worldwide regulatory guidelines and drug development processes.

Responsibilities

• Manage labeling content for multiple markets and products.
• Guide health authority discussions and prepare regulatory submissions.
• Oversee labeling documents (CCDS, USPI, EUPI) and labeling governance.
• Provide scientific and regulatory guidance and drive process improvements; support inspections and audits.

Skills

Project leadership

Scientific communication

Document management

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Senior Manager, Regulatory Affairs Labeling Product Leader to develop and execute global labeling strategies for innovative medicines. You will lead target labeling development, align content with global regulatory requirements, and collaborate with clinical, safety, market access, and medical teams to ensure compliance and strategic alignment.

The role involves managing labeling content across multiple markets, guiding health authority discussions, and leading