Regulatory Operations Specialist

ORIC Pharmaceuticals • San Diego, CA

5d • $80,000 - $90,000 • Onsite

About The Position

ORIC Pharmaceuticals is seeking an experienced Regulatory Operations Specialist to maintain accurate records of regulatory submissions and health authority correspondence and support electronic publishing of regulatory submissions. The role ensures regulatory documentation is complete, traceable, and compliant with health authority and internal standards.

The specialist archives US and ex-US regulatory submissions and health authority correspondence, tracks health authority interactions and responses in a Regulatory Information Management system, and publishes submissions using eCTD publishing software. The role also supports publishing documents such as nonclinical reports, clinical study reports, and Investigator’s Brochures; performs quality control of eCTD submissions; assists with electronic document and publishing systems; and monitors evolving global regulatory requirements and industry trends. Duties must be performed in keeping with company values, policies, and applicable regulations.

Requirements

• 1–3 years of industry experience in an industry-related position.
• BS degree in a relevant field or equivalent.
• Experience supporting regulatory affairs processes and systems for clinical and commercial activities.
• Effective oral and written communication skills.
• Strong interpersonal skills.
• Ability to solve challenging issues and apply critical thinking.
• Attention to detail.
• Excellent organizational ability, including the ability to multitask and shift priorities as needed.

Nice To Haves

• Knowledge of and hands-on experience with Regulatory Information Management systems, such as Veeva RIM, or regulatory submission publishing systems.

Responsibilities

• Archive US and ex-US regulatory submissions and health authority correspondence, ensuring documents are version-controlled and retrievable.
• Track health authority interactions and responses in a Regulatory Information Management system.
• Publish regulatory submissions using eCTD publishing software and submit them to health authorities, such as through the FDA Electronic Submission Gateway (ESG).
• Support publishing of documents including nonclinical reports, clinical study reports, and Investigator’s Brochures using MS Word and PDF publishing tools.
• Conduct quality control checks on eCTD submissions, including hyperlinking, bookmarking, and validation against technical specifications.
• Assist with maintenance and management of electronic document management systems and publishing systems.
• Stay up to date with evolving global regulatory requirements, guidelines, and industry trends that could affect regulatory submissions and approval timelines.
• Perform duties in accordance with the company’s core values, policies, and applicable regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level