Associate Director, Regulatory Affairs Labeling Product Leader

Role:

Associate Director, Global Labeling Product Leader within Johnson & Johnson's Innovative Medicine R&D, responsible for developing and executing global labeling strategies for pharmaceutical products.

Responsibilities:

Leading target labeling development, collaborating with cross-functional teams (clinical, safety, regulatory, commercial), and aligning labeling strategies with global regulatory and product plans.

• Analyzing competitor labeling, guiding local label content, managing health authority discussions and maintaining high-quality labeling documentation.
• Stakeholder engagement spans global regulatory teams and external partners, with representation at governance forums like Labeling Committee.

Qualifications:

• Bachelor's degree in a scientific discipline (advanced degree preferred).
• At least 8 years of experience, including 6+ years in regulatory labeling content development, especially for pharmaceutical products and NME submissions.
• Experience in the pharmaceutical industry, understanding drug development processes, and familiarity with worldwide regulatory guidelines.
• Skills in scientific communication, project leadership in a matrix environment, and document management.
• Position may involve some collaboration with external partners.

Location:

Hybrid, in Raritan, NJ; Titusville, NJ; or Horsham, PA.