Senior Manager, North America Regulatory Liaison

Johnson & Johnson seeks a Senior Manager for North America Regulatory Liaison within Innovative Medicine, responsible for developing regulatory strategy and executing submissions for immunology projects. This hybrid role, based in Pennsylvania or New Jersey, requires strategic leadership to guide product development pathways and manage Health Authority interactions.

Responsibilities

• Develop and execute North America regulatory strategy for assigned immunology projects
• Lead planning, preparation, and delivery of regulatory submissions across product lifecycle
• Serve as primary point of contact and lead interactions with FDA and other Health Authorities
• Partner with global and cross-functional teams to align submission and interaction plans
• Identify process improvements and drive operational excellence across regulatory functions

Requirements

• Bachelor's degree in scientific or technical discipline; advanced degree (Master's, PharmD, Ph.D.) preferred
• Minimum 8 years regulatory experience with Bachelor's; 6 years with Master's/PharmD; 4 years with Ph.D.
• Pharmaceutical, biotech, or OTC industry experience required
• Expert knowledge of clinical drug development and regulatory pathways
• Demonstrated experience managing lifecycle submissions (IND, NDA, CTA, MAA)
• Proven track record of FDA and global Health Authority interactions
• Immunology therapeutic area experience preferred