Senior Publisher – Regulatory Operations

Shionogi Inc. (U.S.)

Senior Regulatory Operations Associate responsible for preparing and submitting FDA and EMA regulatory documents. Leading projects and collaborating with cross-functional teams in a pharmaceutical setting.

Posted 5/8/2026contractRemote • New Jersey • 🇺🇸 United StatesSenior💰 $48 - $70 per hourWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Lead 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).
Participate in project-planning meetings to provide input on submission timelines in collaboration with Manager, Regulatory Operations.
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 managing the lifecycle of submission-related documents.
Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements, as well as ensure metadata is correctly applied.
Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives while continuing to stay well-informed on future developments.
Actively participate in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklist, templates) for preparing submissions and regulatory information management, in addition to assisting in the creation and maintenance of templates.
Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive)
Develop global partnerships across the organization to help implement Regulatory Operations’ initiatives by attending and participating in Project Teams if deemed appropriate by manager.
Maintain knowledge of local and global regulatory submission requirements.
Assist in supporting Regulatory Operations’ technology including, but not limited to publishing tools, databases, and servers.
Ensure adherence to Company Standard Operating Procedures.
Mentor and support junior-level team members as needed to help facilitate the team’s growth.
Perform managerial activities in manager’s absence.
Other duties as assigned.

Requirements

What you’ll need

Bachelors’ degree, preferably in a life science or a related field or a minimum of 3-4 years of experience in a small pharmaceutical environment.
Proven experience in preparing and submitting regulatory documents, including nonclinical, clinical, CMC, DMF, and labeling/SPL., in eCTD format.
Thorough knowledge and understanding of relevant FDA guidances, ICH guidelines and other regulatory requirements.
Proficiency in using: Software and tools for publishing, submissions, and tracking (i.e. MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system) Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway), and MHRA Portal
Able to assist with maintenance of document management system
Capable of reviewing documentation with a high degree of attention to detail.
Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team ‐ oriented environment.
Adept at effective time management in handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
Proactive to identify issues and propose solutions as necessary.

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. Senior Publisher – Regulatory Operations 🔥 6 minutes ago 🏖️ New Jersey – Remote 💵 $48 - $70 / hour ⏳ Contract/Temporary 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Lead 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).
Participate in project-planning meetings to provide input on submission timelines in collaboration with Manager, Regulatory Operations.
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 managing the lifecycle of submission-related documents.
Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements, as well as ensure metadata is correctly applied.
Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives while continuing to stay well-informed on future developments.
Actively participate in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklist, templates) for preparing submissions and regulatory information management, in addition to assisting in the creation and maintenance of templates.
Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive)
Develop global partnerships across the organization to help implement Regulatory Operations’ initiatives by attending and participating in Project Teams if deemed appropriate by manager.
Maintain knowledge of local and global regulatory submission requirements.
Assist in supporting Regulatory Operations’ technology including, but not limited to publishing tools, databases, and servers.
Ensure adherence to Company Standard Operating Procedures.
Mentor and support junior-level team members as needed to help facilitate the team’s growth.
Perform managerial activities in manager’s absence.
Other duties as assigned. 🎯 Requirements
Bachelors’ degree, preferably in a life science or a related field or a minimum of 3-4 years of experience in a small pharmaceutical environment.
Proven experience in preparing and submitting regulatory documents, including nonclinical, clinical, CMC, DMF, and labeling/SPL., in eCTD format.
Thorough knowledge and understanding of relevant FDA guidances, ICH guidelines and other regulatory requirements.
Proficiency in using: Software and tools for publishing, submissions, and tracking (i.e. MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system) Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway), and MHRA Portal
Able to assist with maintenance of document management system
Capable of reviewing documentation with a high degree of attention to detail.
Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team ‐ oriented environment.
Adept at effective time management in handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
Proactive to identify issues and propose solutions as necessary. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Senior SAP DRC – Document & Reporting Compliance Techno-Functional Consultant 🕒 April 29 Simple Software Solutions Group, Inc 51 - 200 🔌 API 🛍️ eCommerce ☁️ SaaS Website LinkedIn All Job Openings Senior SAP DRC Consultant advising on compliance and statutory reporting capabilities for clients. Lead implementation and configuration of SAP DRC across multiple regions and regulatory environments. 🇺🇸 United States – Remote 💵 $95 - $120 / hour ⏳ Contract/Temporary 🟠 Senior 🚔 Compliance NERC Compliance Analyst 🕒 April 27 HSI 501 - 1000 📚 Education 🏢 Enterprise ☁️ SaaS Website LinkedIn All Job Openings NERC Compliance Analyst supporting utilities sector by evaluating adherence to NERC Reliability Standards. Conducting in-depth reviews and developing compliance process improvements. 🇺🇸 United States – Remote 💰 Private Equity Round on 2023-11 ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Governance Consultant – GRC Practice 🕒 April 4 Artemis Connection 51 - 200 🤝 B2B 🤝 Non-profit Website LinkedIn All Job Openings Governance Consultant enhancing compliance practices across sectors, assessing current governance, designing structures, and driving adoption. Client-facing role focusing on strategic decision-making in governance and risk. 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Risk Management Consultant – GRC Practice 🕒 April 4 Artemis Connection 51 - 200 🤝 B2B 🤝 Non-profit Website LinkedIn All Job Openings Risk Management Consultant at Artemis Connection helping clients build and mature enterprise risk programs. Focused on strategic, operational, regulatory, and reputational risks with an emphasis on cybersecurity. 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Compliance Consultant – GRC Practice 🕒 April 4 Artemis Connection 51 - 200 🤝 B2B 🤝 Non-profit Website LinkedIn All Job Openings Compliance Consultant delivering compliance assessments and advisory engagements across various frameworks for GRC practice. Managing client relationships and contributing to business development activities. 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

regulatory applicationssubmission maintenanceregulatory submission documentsregulatory information managementGood Manufacturing PracticesSOPseCTD formatFDA guidancesICH guidelinesattention to detail

Soft Skills

collaborationcommunicationtime managementproblem-solvingmentoringteam-orientedproject planningorganizational skillsproactive approachleadership