Regulatory Operations & Submissions Specialist

ORIC Pharmaceuticals, Inc.; San Diego (CA); On-site; USD 80,000 - 90,000; Full time

Job summary

ORIC Pharmaceuticals, Inc. is seeking a Regulatory Operations Specialist to maintain regulatory submissions records and support eCTD publishing for US and international submissions.

The role focuses on ensuring accuracy, traceability, and compliance with health authority standards. The ideal candidate has 1–3 years in regulatory affairs, a BS in a relevant field, and experience with RIM or publishing systems.

Qualifications

• 1–3 years of industry experience in a related role.
• BS degree in a relevant field or equivalent.
• Experience supporting regulatory affairs processes and systems.
• Familiarity with RIM or publishing systems is a plus.

Responsibilities

• Archive regulatory submissions (US and ex-US) with version control.
• Own tracking of health authority interactions in a Regulatory Information Management system.
• Publish submissions using eCTD publishing software and submit to FDA ESG.
• Publish documents (nonclinical reports, clinical study reports, Investigator's Brochure) with Word/PDF tools.
• Perform QC on eCTD submissions (hyperlinks, bookmarks, specs).
• Assist maintenance of document management and publishing systems.
• Stay updated on global regulatory requirements and timelines.

Skills

Regulatory operations

Regulatory submissions

Documentation control

Attention to detail

Communication skills

Education

Bachelor's degree in a relevant field

Tools

Veeva RIM

Regulatory submission publishing systems

Job description

ORIC Pharmaceuticals, Inc. is seeking a Regulatory Operations Specialist to maintain regulatory submissions records and support eCTD publishing for US and international submissions.

The role focuses on ensuring accuracy, traceability, and compliance with health authority standards. The ideal candidate has 1–3 years in regulatory affairs, a BS in a relevant field, and experience with RIM or publishing systems.