Associate Director, Regulatory Affairs Labeling Product Leader

Scorpion Therapeutics; Horsham (PA); Hybrid; USD 200,000 - 260,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine R&D seeks an Associate Director, Global Labeling Product Leader to lead global labeling strategy and development for assigned products. This role operates within a complex, cross-functional environment and interfaces with regulatory bodies worldwide.

You will collaborate closely with clinical, safety, market access, and medical teams, ensuring alignment with regulatory expectations and product objectives while preparing for inspections and audits.

Qualifications

• 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.

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.
• Support labeling inspections and audits.

Skills

Regulatory experience

Labeling content development

Cross-functional leadership

Project management

Communication

Organizational skills

Education

Bachelor's in a scientific discipline

Advanced degree preferred

Job description

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.