Senior Regulatory Program Lead, Submissions & Strategy

Shionogi Inc. (U.S.); Florham Park (NJ); Sur place; USD 140 000 - 170 000; Plein temps

Résumé du poste

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

You will partner with global leads and cross-functional teams to ensure timely, compliant deliverables and effective regulatory interactions. The role emphasizes coordination, planning, and execution across development and marketed products, with oversight on complex submissions and timelines.

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• 5+ years of pharmaceutical, biotechnology, or related industry experience, including regulatory affairs or regulatory program support.
• Experience supporting global regulatory submissions and lifecycle management activities, coordinating cross-functional deliverables.

Responsabilités

• Accountable for end-to-end operational delivery of submissions, including planning, readiness, timelines, and tracking.
• Serves as operational contact for designated applications and supports IND/NDA lifecycle maintenance.
• Develops and adjusts submission plans and resolves cross-functional dependencies.
• Schedules submissions and coordinates document preparation, review, and submission.
• Performs document reviews for completeness, consistency, and submission readiness.
• Leads operational cross-functional coordination for regulatory deliverables and maintains master timelines.

Connaissances

Regulatory affairs

Project coordination

Cross-functional leadership

Formation

Bachelor’s degree in a scientific field

Outils

Document management systems

Project planning tools

Description du poste

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

You will partner with global leads and cross-functional teams to ensure timely, compliant deliverables and effective regulatory interactions. The role emphasizes coordination, planning, and execution across development and marketed products, with oversight on complex submissions and timelines.