Manager, Regulatory Affairs – GDP

Shionogi Inc. (U.S.)

. Serve as the Regulatory Affairs lead for assigned clinical programs and submissions, acting as the primary point of contact for regulatory activities.

Posted 5/7/2026full-timeFlorham Park • New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $150,000 per yearWebsite

About the role

Key responsibilities & impact

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 planning through 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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

EEO Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.

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Hard Skills & Tools

regulatory submissionsINDsNDAsregulatory strategiesregulatory requirementsrisk assessmentissue resolutionlifecycle managementpublishing processesQC review

Soft Skills

leadershipcommunicationcritical thinkingcross-functional collaborationorganizational skillsproblem-solvingstakeholder managementattention to detailstrategic thinkingalignment