Regulatory Submissions & Records Specialist

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

Job summary

ORIC Pharmaceuticals in San Diego is seeking an experienced Regulatory Operations Specialist to maintain accurate regulatory records and support electronic publishing of submissions, ensuring compliance with health authority standards and internal guidelines.

The role will archive US and ex-US submissions, track interactions in a Regulatory Information Management system, publish eCTD submissions (FDA ESG), and perform quality checks while staying current with evolving global regulatory

Qualifications

• BS degree in a relevant field or equivalent.
• 1–3 years of industry experience in regulatory affairs.
• Familiarity with regulatory information management systems such as Veeva RIM.

Responsibilities

• Archive regulatory submissions (US and ex-US) with version control.
• Track health authority interactions in a Regulatory Information Management system.
• Publish submissions using eCTD publishing tools and submit to authorities (e.g., ESG).
• Perform QC on eCTD submissions (hyperlinks, bookmarks, validation).
• Assist with maintenance of electronic document management and publishing systems.
• Stay updated on global regulatory requirements and timelines.

Skills

Regulatory processes

Communication skills

Attention to detail

Education

BS Degree

Tools

Veeva RIM

Regulatory publishing systems

Job description

ORIC Pharmaceuticals in San Diego is seeking an experienced Regulatory Operations Specialist to maintain accurate regulatory records and support electronic publishing of submissions, ensuring compliance with health authority standards and internal guidelines.

The role will archive US and ex-US submissions, track interactions in a Regulatory Information Management system, publish eCTD submissions (FDA ESG), and perform quality checks while staying current with evolving global regulatory