US Regulatory Affairs Director: Strategy & Submissions Lead

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

Job summary

Shionogi Inc. in Florham Park, NJ, seeks a Director, Regulatory Affairs Lead (Finance) to develop and execute global regulatory strategies for development programs and U.S.

lifecycle plans for marketed products, aligning regulatory requirements with business objectives. You will lead major submissions (INDs, NDAs, BLAs), manage regulatory risk, mentor staff, and partner with cross-functional teams and health authorities to advance programs on schedule.

Qualifications

• Minimum 10 years Regulatory Affairs experience in pharma/biopharma.
• Experience independently leading regulatory strategy for complex development programs.
• Extensive experience supporting US and/or global regulatory strategy across drug development.
• Strong knowledge of US regulatory requirements and complex development programs.

Responsibilities

• Develops and implements global regulatory strategies for assigned development programs and U.S. lifecycle strategies for marketed products.
• Leads major regulatory submissions (INDs, NDAs, BLAs, MAAs) and lifecycle management activities.
• Provides strategic regulatory guidance to cross-functional teams and senior leadership.
• Identifies regulatory risks, opportunities, and mitigation strategies to support product development and approvals.

Skills

Regulatory strategy

Leadership

Cross-functional teaming

Project management

Regulatory submissions

Communication

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Shionogi Inc. in Florham Park, NJ, seeks a Director, Regulatory Affairs Lead (Finance) to develop and execute global regulatory strategies for development programs and U.S.

lifecycle plans for marketed products, aligning regulatory requirements with business objectives. You will lead major submissions (INDs, NDAs, BLAs), manage regulatory risk, mentor staff, and partner with cross-functional teams and health authorities to advance programs on schedule.