Regulatory Operations Specialist

ORIC Pharmaceuticals • San Diego, CA

5d • 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 to support electronic publishing of regulatory submissions. The role ensures regulatory documentation is complete, traceable, and compliant with health authority and internal standards. The position supports regulatory affairs processes and systems for clinical and commercial activities.

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, think critically, and maintain 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 using 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 the maintenance and management of electronic document management systems and publishing systems.
• Keep 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