Regulatory Operations – Level 2 – Publisher

Shionogi Inc. (U.S.)

. Support in the preparation and submittal of regulatory applications and on‐going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA, DMF).

Posted 4/21/2026contractFlorham Park • New Jersey • 🇺🇸 United StatesJuniorMid-Level💰 $40 - $57 per hourWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Support in the preparation and submittal of regulatory applications and on‐going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA, DMF).
Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions).
Provide technical expertise to cross-functional teams on structure of compliant documents for electronic submissions.
Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to obtain the necessary information to ensure timely submission of regulatory documents.
Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
Perform quality control checks on documents to ensure accuracy and completeness, as well as resolve any issues that arise.
Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
Maintain knowledge of local regulatory submission requirements.
Ensure adherence to Company Standard Operating Procedures.
Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives.
Supports in the review of Regulatory Operations processes (SOPs, work instructions, checklists, templates) for preparing submissions and regulatory information management.
Other duties as assigned.

Requirements

What you’ll need

Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs.
Prior knowledge of CTAs/MAAs a plus.
Bachelor’s degree preferred
Acquired knowledge of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents.
Familiar with regulatory guidelines, such as FDA, EMA, MHRA, and Health Canada.
Knowledge and understanding of relevant Health Authority guidance and other regulatory requirements.
Proficiency in using: MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system Veeva Vault RIM ESG Gateway.
Capable of reviewing documentation with a high degree of attention to detail.
Effective communicator adept at communicating with cross-functional teams, regardless of level.
Adept at handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
Ability to work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team‐oriented environment.
Capable of managing time effectively, prioritize tasks in order to meet objectives in a timely manner.
Adept at identifying issues and propose solutions as necessary.

Benefits

Comp & perks

Health insurance
Paid time off
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

eCTD publishingregulatory submissionsquality controldocument reviewregulatory information managementsubmission document preparationcompliance documentationattention to detailproject managementproblem solving

Soft Skills

effective communicationcollaborationtime managementprioritizationattention to detailadaptabilityteam-orientedcross-functional teamworkissue identificationsolution proposal