Regulatory Specialist

Job Title:

Regulatory Specialist Job Description

The Regulatory Specialist supports key regulatory submissions by coordinating, tracking, and organizing documentation for IND filings. This role focuses on regulatory operations and document management, ensuring that all records are accurate, compliant, and audit-ready while partnering closely with internal stakeholders in a pharmaceutical, biotech, or drug discovery environment.

• Support IND filing activities by coordinating and tracking regulatory documents throughout the submission lifecycle.
• Manage document flow to ensure proper version control, routing, and archival practices are consistently followed.
• Maintain regulatory submission trackers and document inventories to provide clear visibility into filing status and outstanding items.
• Coordinate collection of required documents from internal stakeholders and follow up to obtain missing information.
• Track Module 2 documentation and verify completeness of all required components prior to submission.
• Support regulatory operations processes and document management activities in alignment with internal procedures and regulatory expectations.
• Ensure regulatory records are organized, audit-ready, and compliant with established company procedures and regulatory standards.
• Assist with electronic document management systems (eDMS) and filing platforms to store, organize, and retrieve regulatory documentation.
• Monitor filing timelines and proactively follow up with stakeholders on outstanding documentation to keep submissions on schedule.
• Maintain accurate records of submissions, amendments, and regulatory correspondence to support traceability and compliance.

• 2–5+ years of experience in Regulatory Affairs Operations, Regulatory Document Management, or Regulatory Publishing support.
• Hands-on experience supporting IND filings within a pharmaceutical, biotech, or drug discovery environment.
• Familiarity with Module 2 documentation and its components in the context of regulatory submissions.
• Experience with document tracking, document routing, and version control processes in a regulated environment.
• Knowledge of eCTD structure and regulatory filing requirements for IND submissions.
• Proficiency with electronic document management systems such as Veeva, Master Control, SharePoint, or similar platforms.
• Strong organizational skills with the ability to manage multiple documents, tasks, and timelines simultaneously.
• High attention to detail to ensure accuracy, completeness, and compliance of all regulatory documentation.

• Experience in regulatory, IND, or related regulatory operations work.
• Comfort working with electronic filing platforms and eDMS tools.
• Ability to collaborate effectively with cross-functional internal stakeholders.
• Strong written and verbal communication skills for clear documentation and stakeholder follow-up.

This position operates in a remote work environment, providing flexibility in work location while maintaining close collaboration with regulatory and cross-functional teams through digital communication and document management systems. The role relies heavily on electronic tools and platforms, including eDMS solutions such as Veeva, Master Control, and SharePoint, to manage, track, and archive regulatory documentation. Working hours are typically aligned with standard business hours, with the need to meet filing timelines and regulatory deadlines.

The remote setting requires a reliable workspace, consistent internet access, and the ability to manage tasks independently while adhering to company procedures and regulatory standards.

This is a Contract position based out of Miami, FL.

The…