Regulatory Affairs Director, NA Oncology

Johnson & Johnson; Spring House (PA); Hybrid; USD 137,000 - 236,000; Full time

Job summary

Johnson & Johnson seeks an Associate Director, Regulatory Affairs, North American Regional Leader to drive regulatory strategy across oncology projects and global dossiers. You will lead the NA content plans and act as the primary US FDA contact.

You will guide submissions from IND/CTA to NDA/BLAs, coordinate Health Authority interactions, and collaborate with cross-functional teams to ensure compliance and timely approvals across pharma, devices, and combo products.

Qualifications

• Bachelor’s degree in scientific or equivalent discipline.
• 8+ years of regulatory experience or a Master’s/PharmD with 6+ years.
• PhD with 4+ years regulatory experience considered.
• Experience with US FDA and global health authorities.
• Experience responding to FDA requests and managing HA interactions.
• Lifecycle management of IND/NDA and other submissions.

Responsibilities

• Establish North American content requirements and timing for global dossiers.
• Serve as primary point of contact for US FDA and Health Authorities.
• Lead regulatory submission strategy and manage inspection-ready materials.
• Coordinate NA post-approval commitments and submissions workflow.
• Develop labeling strategies and NA documentation alignment with CCDS.
• Collaborate with cross-functional teams on development documents.

Skills

Regulatory strategy

FDA liaison

IND/NDA submissions

Lifecycle management

Cross-functional collaboration

Clinical development understanding

Education

Bachelor’s degree in scientific or equivalent

Master’s degree/ PharmD

PhD

Job description

Johnson & Johnson seeks an Associate Director, Regulatory Affairs, North American Regional Leader to drive regulatory strategy across oncology projects and global dossiers. You will lead the NA content plans and act as the primary US FDA contact.

You will guide submissions from IND/CTA to NDA/BLAs, coordinate Health Authority interactions, and collaborate with cross-functional teams to ensure compliance and timely approvals across pharma, devices, and combo products.