Regulatory Affairs Leader, US & Global Strategy

Shionogi Inc.; Florham Park (NJ); On-site; USD 210,000 - 250,000; Full time

Job summary

Shionogi Inc. seeks a Director, Regulatory Affairs to lead global regulatory strategies for development programs and U.S. lifecycle planning for marketed products.

You will partner with cross-functional teams to shape submissions, manage agency interactions, and ensure timely regulatory delivery. The ideal candidate has 10+ years of regulatory experience in pharma/biopharma, a life-sciences degree (advanced degree preferred), and a proven record leading major submissions (INDs, NDAs, BLAs) and

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 10+ years regulatory affairs experience in pharma/biopharma.
• Experience leading major regulatory submissions (INDs, NDAs, BLAs) and lifecycle management.

Responsibilities

• Develops global regulatory strategies for development programs and U.S. lifecycle strategies for marketed products.
• Lead preparation and submission of regulatory documents; manage agency interactions.
• Provide strategic regulatory guidance and risk mitigation across programs.

Skills

Regulatory strategy

Leadership

Cross-functional

Project management

Communication

Risk assessment

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Job description

Shionogi Inc. seeks a Director, Regulatory Affairs to lead global regulatory strategies for development programs and U.S. lifecycle planning for marketed products.

You will partner with cross-functional teams to shape submissions, manage agency interactions, and ensure timely regulatory delivery. The ideal candidate has 10+ years of regulatory experience in pharma/biopharma, a life-sciences degree (advanced degree preferred), and a proven record leading major submissions (INDs, NDAs, BLAs) and