Associate Director, Regulatory Affairs Labeling Product Leader

Role

Associate Director, Global Labeling Product Leader within Johnson & Johnson’s Innovative Medicine R&D, leading global labeling strategy and development for assigned products.

Responsibilities

• drive labeling strategy aligned with regulatory and product objectives;
• lead target and primary labeling development, revisions, and approval processes;
• collaborate cross-functionally with clinical, safety, market access, and medical teams;
• communicate with Health Authorities;
• and support labeling inspections and audits.

Requirements

• Bachelor’s in a scientific discipline (advanced degree preferred);
• 8+ years of pharmaceutical regulatory experience with at least 6 years focused on labeling content development and review;
• knowledge of worldwide regulatory guidelines;
• experience managing complex projects and cross-functional teams;
• excellent communication and organizational skills.

High-Value

• experience with target labeling development or NME submissions;
• familiarity with global labeling standards, risk mitigation, and regulatory interactions;
• ability to manage multiple products and projects independently;
• strong scientific communication skills.

Work Setup

Hybrid in Raritan, NJ; Titusville, NJ; or Horsham, PA; with potential external collaboration.

Travel

Travel not explicitly stated.