Senior Regulatory Programs Lead: Submissions & Strategy

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

Job summary

Shionogi Inc. in Florham Park, NJ, seeks a Regulatory Program Support professional to manage end-to-end submission delivery, planning, and cross-functional coordination across development programs and marketed products.

The role partners with the global regulatory lead, ensuring timely, compliant submissions and robust documentation, while guiding risk assessments and process improvements in a dynamic, fast-paced environment.

Qualifications

• Bachelor's degree in a scientific or related discipline.
• 5+ years of pharmaceutical/biotechnology regulatory affairs or regulatory program support experience.
• Experience supporting global regulatory submissions and lifecycle management.
• Working knowledge of U.S. regulatory requirements and IND/NDA processes.

Responsibilities

• Accountable for end-to-end operational delivery of submissions, including planning, document readiness, timelines, and tracking.
• Act as operational point of contact for designated applications; support IND/NDA lifecycle maintenance.
• Develop and adjust regulatory submission plans; coordinate cross-functional dependencies.
• Schedule regulatory submissions and coordinate preparation, review, and submission of documents.
• Perform document reviews for completeness, consistency, and submission readiness; ensure proper annotations.
• Contribute to major regulatory submissions by drafting sections and QC reviews.

Skills

Regulatory submissions

Cross-functional coordination

Project management

Attention to detail

Education

Bachelor's degree in science

Job description

Shionogi Inc. in Florham Park, NJ, seeks a Regulatory Program Support professional to manage end-to-end submission delivery, planning, and cross-functional coordination across development programs and marketed products.

The role partners with the global regulatory lead, ensuring timely, compliant submissions and robust documentation, while guiding risk assessments and process improvements in a dynamic, fast-paced environment.