Associate I​/II, Regulatory Operations

Role Summary

The Associate I/II, Regulatory Operations will provide essential regulatory operations and document management support across Capricor’s development and potential commercial programs. This role is primarily responsible for tracking regulatory deliverables, maintaining document repositories and archives, and assisting with submission readiness, publishing, and lifecycle management activities. The Associate will collaborate closely with Regulatory Affairs, CMC, Clinical, Quality, Manufacturing, and other cross‑functional teams to ensure regulatory documents are complete, accurate, current, and readily available to support BLA submissions, regulatory interactions, and ongoing compliance in a fast‑paced biotech environment.

• Track regulatory deliverables, milestones, and timelines across development programs (including BLA‑related activities for Deramiocel), ensuring visibility, proactive risk identification, and on‑time completion
• Maintain regulatory document repositories (e.g., eCTD‑compliant systems), including version control, accuracy checks, and archival of approved/final documents
• Support regulatory publishing activities, including document compilation, formatting, quality checks, hyperlinking/bookmarking, and coordination of submission components under guidance from Regulatory Affairs
• Coordinate with cross‑functional teams (Regulatory Affairs, CMC, Clinical, Quality, Manufacturing, etc.) to collect, track, and organize required submission deliverables and supporting documentation
• Perform detailed document quality checks to ensure formatting, completeness, consistency, and adherence to regulatory standards (e.g., FDA eCTD specifications), internal procedures, and ICH guidelines
• Assist in the preparation and maintenance of submission trackers, document lists, regulatory databases, and correspondence logs
• Support post‑submission activities, including filing of regulatory correspondence, document updates, tracking of queries/responses, and maintenance of submission history
• Contribute to the implementation and maintenance of Regulatory Operations processes, templates, tools, and SOPs to enhance efficiency and compliance
• Monitor internal timelines and proactively communicate potential risks, delays, or issues to Regulatory Affairs leadership
• Support inspection and audit readiness by ensuring regulatory records are complete, current, organized, and readily retrievable
• Perform other duties as may be assigned from time to time

• Required:
  
  Bachelor’s degree in Life Sciences, Regulatory Affairs, or a closely related field
• Required:
  
  Associate I: 0–2 years of experience in regulatory operations, document management, publishing, or a related function in the pharmaceutical/biotech industry;
  Associate II: 2–4 years of relevant experience in regulatory operations, regulatory affairs support, or submissions management
• Preferred:
  Familiarity with regulatory submission structures and formats (e.g., eCTD for IND, BLA, NDA, CTD)
• Preferred:
  Experience with electronic document management systems (EDMS), publishing tools (e.g., Veeva RIM, Lorenz docu Bridge, or similar), and tracking databases
• Required:
  
  Strong organizational skills with meticulous attention to detail and a high degree of accuracy
• Required:
  
  Ability to manage multiple deliverables, prioritize effectively, and meet tight deadlines in a dynamic, fast‑paced environment
• Required:
  
  Clear and professional written and verbal communication skills to facilitate effective cross‑functional collaboration
• Required:
  
  Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat for document handling and quality checks
• Preferred:
  Knowledge of FDA regulations, ICH guidelines, and GxP principles

• Primarily office‑based with tasks focused on regulatory documentation, electronic submissions, and cross‑functional coordination
• Requires prolonged periods of computer use for document review, compilation, quality checking, and data entry
• May involve occasional lifting of office materials up to 15 pounds
• Ability to navigate standard office environments and travel occasionally for regulatory meetings, training, or conferences (as needed)