Senior Regulatory Program Lead - Submissions & Ops

Shionogi Inc. in; Florham Park (NJ); On-site; USD 140,000 - 170,000; Full time

Job summary

Shionogi Inc. in Florham Park, NJ seeks a Senior Manager, Regulatory Program Support (RPS) to lead end-to-end regulatory submissions and program execution.

You will partner with the global regulatory lead and cross‑functional teams to plan, track, and deliver compliant regulatory activities across development and commercial programs. The role requires strong organizational skills, experience with IND/NDA, and ability to manage complex timelines while mentoring junior staff.

Qualifications

• Bachelor's degree in a scientific or related discipline.
• 5 years in pharma/biotech with regulatory affairs or regulatory program support.
• Experience supporting global regulatory submissions and lifecycle management.
• Knowledge of U.S. regulatory requirements, IND/NDA lifecycle maintenance.

Responsibilities

• Accountable for end-to-end operational delivery of submissions, including planning and tracking.
• Acts as operational contact for designated applications and supports lifecycle maintenance.
• Develops regulatory submission plans and coordinates cross-functional activities.
• Schedules submissions and coordinates preparation, review, and submission of documents.
• Performs QC reviews of labeling components and maintains regulatory timelines.

Skills

Project coordination

Regulatory submissions

Cross-functional collaboration

Regulatory knowledge

Communication

Education

Bachelor's degree in a scientific field

Tools

Document management systems

Project planning tools

Office software

Job description

Shionogi Inc. in Florham Park, NJ seeks a Senior Manager, Regulatory Program Support (RPS) to lead end-to-end regulatory submissions and program execution.

You will partner with the global regulatory lead and cross‑functional teams to plan, track, and deliver compliant regulatory activities across development and commercial programs. The role requires strong organizational skills, experience with IND/NDA, and ability to manage complex timelines while mentoring junior staff.