Remote Regulatory Specialist: IND Filings

Actalent; United States; Remote; USD 52,000 - 69,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Job summary

Actalent is seeking a Regulatory Specialist to support IND submissions by coordinating, tracking, and organizing regulatory documentation in a pharma/biotech setting. This remote role emphasizes regulatory operations, document management, and audit readiness in collaboration with internal stakeholders.

The position requires 2–5+ years in Regulatory Affairs Operations, familiarity with Module 2 documentation, eCTD structure, and experience with eDMS tools such as Veeva, MasterControl, or

Qualifications

• 2–5+ years in Regulatory Affairs Operations or Regulatory Document Management
• Experience supporting IND filings in pharma/biotech
• Familiarity with Module 2 documentation and its components
• Proficiency with electronic document management systems (Veeva, MasterControl, SharePoint)

Responsibilities

• Coordinate and track regulatory documents throughout the submission lifecycle
• Maintain document flow with version control, routing, and archival practices
• Maintain regulatory submission trackers and inventories for visibility
• Coordinate collection of required documents from internal stakeholders
• Track Module 2 documentation and verify completeness before submission
• Support regulatory operations processes and document management per internal procedures
• Ensure regulatory records are audit-ready and compliant with standards
• Assist with eDMS and filing platforms to store and retrieve documentation
• Monitor filing timelines and follow up with stakeholders
• Maintain records of submissions, amendments, and regulatory correspondence

Skills

Regulatory operations

Regulatory document management

IND filings

Module 2 knowledge

eCTD knowledge

eDMS tools

Tools

Veeva

MasterControl

SharePoint

Job description

Actalent is seeking a Regulatory Specialist to support IND submissions by coordinating, tracking, and organizing regulatory documentation in a pharma/biotech setting. This remote role emphasizes regulatory operations, document management, and audit readiness in collaboration with internal stakeholders.

The position requires 2–5+ years in Regulatory Affairs Operations, familiarity with Module 2 documentation, eCTD structure, and experience with eDMS tools such as Veeva, MasterControl, or