Associate Director, Regulatory Affairs Labeling Product Leader (Pharmaceutical Labeling)

Location: Hybrid role based in Raritan, New Jersey; Titusville, New Jersey; or Horsham, Pennsylvania, United States

Base pay range: $137,000–$235,750 per year

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative medicines designed to prevent, treat, and cure complex diseases.

What you will do

• Drive global labeling strategy for assigned pharmaceutical products, including competitor analysis, labeling guidance, trends, risks, and mitigation plans.
• Lead target labeling development and oversee primary labeling, including CCDS, USPI, patient labeling, EUPI, and derived documents.
• Partner with Global Regulatory Leads and clinical, safety, market access, commercial, and medical affairs functions.
• Lead Labeling Working Groups, strategic labeling discussions, governance presentations, and Health Authority labeling strategy discussions.
• Provide guidance on labeling content, processes, timelines, scientific integrity, and issue resolution.
• Support continuous improvement initiatives, inspections, audits, and collaboration with external partners.

Requirements

• Bachelor’s degree in a scientific discipline and at least 8 years of professional experience.
• At least 6 years of direct regulatory labeling content experience developing and writing labeling for pharmaceutical products or equivalent.
• Relevant pharmaceutical industry experience and understanding of pharmaceutical drug development.
• Knowledge of worldwide regulatory guidelines and their application to labeling.
• Experience leading project teams in a matrix environment and continuous improvement projects.
• Exceptional communication, organizational, negotiation, partnering, prioritization, and independent working skills.

Nice to have

• Advanced scientific degree such as a Master’s, PhD, or PharmD.
• Experience with target labeling development or New Molecular Entity submissions.
• Experience managing multiple complex products and projects simultaneously.
• Experience with document management systems and complex labeling compounds.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Eligibility for pension and 401(k) savings plans.
• Participation in a long-term incentive program.
• Vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and other time-off benefits.