Regulatory Information Manager

Dianthus Therapeutics, Inc.

Regulatory Information Manager supporting traceable regulatory systems and submissions at Dianthus Therapeutics. Collaborating with R&D to ensure compliance and readiness in regulatory matters.

Posted 5/21/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Work across the regulatory team supporting all document management activities
Support implementation and maintenance of Regulatory Information Management System across all programs.
Archive regulatory submission documents, content plans and health authority queries for easy searching and retrieval
Own and maintain document repositories, trackers and dashboards, providing up to date, accurate information as a communication tool within R&D
Authoring of departmental documents including SOPs to support the systems and processes used in Regulatory Affairs and Regulatory Development Plans
Support departmental initiatives, including process and infrastructure development, regulatory intelligence, and budgeting

Requirements

What you’ll need

Scientific Bachelor's degree and 2-3 years’ experience in Pharma/Biotech industry
Demonstrated strong organizational skills and a self-starter
Project management mindset
Aptitude for learning technology and software
Ability to work effectively in a fast-paced, collaborative, and dynamic environment.
Experience working in Regulatory Affairs department an asset
Previous experience working in Veeva RIM an asset
Strong interpersonal skills and the ability to collaborate effectively with subject matter experts.
Demonstrated problem-solving ability, flexibility, and teamwork.
Excellent communication, writing, and presentation skills
Advanced experience working in MS Office, Adobe Pro, and Smartsheet

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Dianthus Therapeutics, Inc. Website LinkedIn All Job Openings 1 - 10 employees Founded 2017 🧬 Biotechnology 💊 Pharmaceuticals 💰 $100M Private Equity Round on 2022-04 Biotechnology
Pharmaceuticals Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment. Regulatory Information Manager Job not on LinkedIn 🔥 7 minutes ago 🇺🇸 United States – Remote ⏰ Full Time 🟢 Junior 🟡 Mid-level 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Work across the regulatory team supporting all document management activities
Support implementation and maintenance of Regulatory Information Management System across all programs.
Archive regulatory submission documents, content plans and health authority queries for easy searching and retrieval
Own and maintain document repositories, trackers and dashboards, providing up to date, accurate information as a communication tool within R&D
Authoring of departmental documents including SOPs to support the systems and processes used in Regulatory Affairs and Regulatory Development Plans
Support departmental initiatives, including process and infrastructure development, regulatory intelligence, and budgeting 🎯 Requirements
Scientific Bachelor's degree and 2-3 years’ experience in Pharma/Biotech industry
Demonstrated strong organizational skills and a self-starter
Project management mindset
Aptitude for learning technology and software
Ability to work effectively in a fast-paced, collaborative, and dynamic environment.
Experience working in Regulatory Affairs department an asset
Previous experience working in Veeva RIM an asset
Strong interpersonal skills and the ability to collaborate effectively with subject matter experts.
Demonstrated problem-solving ability, flexibility, and teamwork.
Excellent communication, writing, and presentation skills
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Hard Skills & Tools

document managementregulatory information managementauthoring SOPsregulatory affairsregulatory development plansproject management

Soft Skills

organizational skillsself-starterinterpersonal skillscollaborationproblem-solvingflexibilityteamworkcommunicationwritingpresentation

Certifications

Bachelor's degree