Regulatory Operations Documentation Specialist

Shionogi Inc. (U.S.)

Support Regulatory Operations with electronic submission documentation. Focus on document formatting, quality control, and communication archiving with Health Authorities.

Posted 6/19/2026contractRemote • New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $40 - $57 per hourWebsite

About the role

Key responsibilities & impact

Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
Assist the archiving and retrieval of documents from offsite storage facilities.
Provide ongoing support to the Regulatory Operations team.

Requirements

What you’ll need

High school degree required; Associate’s degree preferred.
Pharmaceutical industry experience is a plus, but not required.
Proficient in MS Office and Acrobat Adobe.
Experience with ISI Toolbox or equivalent software packages.
Experience with database systems; Veeva is a plus.
High level of attention to detail and accuracy in work.
Effective time management and organizational skills.
Strong written and verbal communication skills.
Able to work within a high-performance, collaborative team environment.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Shionogi Inc. (U.S.) Website LinkedIn All Job Openings 501 - 1000 employees Founded 2001 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance Biotechnology
Pharmaceuticals
Healthcare Insurance Shionogi Inc. (U. S. ) is a pharmaceutical company committed to improving patient lives by developing innovative treatments for challenging diseases. Since its establishment in 1878, Shionogi has focused on addressing global health issues such as antimicrobial resistance and COVID-19, with a strong emphasis on research and development of novel antibiotics and antiviral medications. The company prioritizes scientific excellence and collaboration with various partners to advance healthcare solutions. Regulatory Operations Documentation Specialist 🔥 15 minutes ago 🏖️ New Jersey – Remote 💵 $40 - $57 / hour ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
Assist the archiving and retrieval of documents from offsite storage facilities.
Provide ongoing support to the Regulatory Operations team. 🎯 Requirements
High school degree required; Associate’s degree preferred.
Pharmaceutical industry experience is a plus, but not required.
Proficient in MS Office and Acrobat Adobe.
Experience with ISI Toolbox or equivalent software packages.
Experience with database systems; Veeva is a plus.
High level of attention to detail and accuracy in work.
Effective time management and organizational skills.
Strong written and verbal communication skills.
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Hard Skills & Tools

document formattingquality controlPDF remediationbookmarkinghyperlinkingdatabase systemsattention to detailtime managementorganizational skillswritten communication

Soft Skills

effective communicationcollaborative teamwork

Certifications

high school degreeAssociate’s degree