Capricor Therapeutics, Inc. · 5 hours ago
Associate I/II, Regulatory Operations
San Diego, CA
Full-time
Onsite
New Grad, Entry, Mid Level
$70K/yr - $90K/yr
0+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The Associate I/II, Regulatory Operations will provide essential regulatory operations and document management support, ensuring regulatory documents are complete and ready for BLA submissions and compliance activities.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's degree in Life Sciences, Regulatory Affairs, or a closely related field
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
Strong organizational skills with meticulous attention to detail and a high degree of accuracy
Ability to manage multiple deliverables, prioritize effectively, and meet tight deadlines in a dynamic, fast-paced environment
Clear and professional written and verbal communication skills to facilitate effective cross-functional collaboration
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat for document handling and quality checks
Preferred
Familiarity with regulatory submission structures and formats (e.g., eCTD for IND, BLA, NDA, CTD)
Experience with electronic document management systems (EDMS), publishing tools (e.g., Veeva RIM, Lorenz docuBridge, or similar), and tracking databases
Knowledge of FDA regulations, ICH guidelines, and GxP principles
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase