Manager, Regulatory Affairs - GDP

Shionogi•Florham Park, NJ

8d•Hybrid

About The Position

The Manager, Regulatory Affairs – Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects, owning regulatory deliverables and acting as a key point of contact for cross-functional teams. The individual operates with a high degree of autonomy for assigned responsibilities, applying regulatory knowledge and critical thinking to interpret data, ensure compliance, and guide regulatory activities with minimal direction. This role contributes to regulatory strategy execution and proactively identifies risks, drives solutions, and escalates as needed to support successful regulatory outcomes.

Requirements

Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry.
Experience supporting US regulatory drug development activities based on FDA and ICH requirements.
Demonstrated experience supporting or leading components of regulatory submissions (e.g., INDs, NDAs) and lifecycle management activities in alignment with FDA and ICH requirements
Experience preparing and maintaining regulatory submissions and source documentation; familiarity with publishing/QC processes.
Ability to independently manage regulatory deliverables from planning through submission, ensuring timely, high-quality outcomes with minimal oversight
Comfortable operating in a fast-paced environment with evolving priorities, applying regulatory knowledge to adapt and respond effectively
Drives alignment and progress across teams without direct authority, effectively partnering with stakeholders to achieve regulatory objectives
Maintains high standards for accuracy, completeness, and compliance across all regulatory deliverables
Identifies risks early, applies sound judgment, and takes appropriate action or escalation to resolve issues
Clearly communicates regulatory considerations, risks, and timelines to cross-functional stakeholders, including presenting to study and project teams as needed
Ability to manage multiple priorities with strong attention to detail while meeting established timelines

Responsibilities

Serve as the Regulatory Affairs lead for assigned clinical programs and submissions, acting as the primary point of contact for regulatory activities
Lead preparation, organization, and QC review of regulatory submissions (e.g., INDs, NDAs, amendments, supplements)
Manage submissions end-to-end, from publishing and final delivery in partnership with Regulatory Operations
Own and drive regulatory deliverables, ensuring alignment with timelines, quality standards, and regulatory requirements
Contribute to the development and execution of regulatory strategies for assigned programs, applying regulatory knowledge and critical thinking
Interpret regulatory requirements and assess their impact on study design, submissions, and documentation
Identify regulatory risks, support development of mitigation strategies, and drive issue resolution or escalation as needed
Lead and/or facilitate cross-functional alignment and provide regulatory guidance to ensure consistency, accuracy, and compliance across deliverables
Represent Regulatory Affairs on cross-functional teams, clearly communicating regulatory considerations, timelines, and risks to stakeholders