Regulatory Submissions & RIM Specialist

ORIC Pharmaceuticals Inc.

San Diego (CA)

On-site

USD 80,000 - 90,000

Full time

8 days ago

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Job summary

ORIC Pharmaceuticals is seeking an experienced Regulatory Operations Specialist in San Diego to maintain records of regulatory submissions and health authority correspondence. You will support electronic publishing of regulatory submissions and ensure documentation is complete and compliant.

The role requires 1–3 years in regulatory affairs, familiarity with RIM systems (e.g., Veeva RIM), and strong communication skills. On-site base salary ranges from $80,000 to $90,000 per year.

Qualifications

  • BS degree in a relevant field (or equivalent).
  • 1–3 years of industry experience in regulatory affairs or related position.
  • Familiarity with regulatory information management (RIM) systems or publishing systems is a plus.
  • Strong written and oral communication and interpersonal skills.

Responsibilities

  • Archive regulatory submissions and health authority correspondence with version control.
  • Track health authority interactions in a Regulatory Information Management system.
  • Publish submissions using eCTD publishing software and submit to health authorities.
  • Publish related documents (nonclinical reports, clinical study reports, Investigator's Brochure) using Word and PDF tools.
  • Perform quality control checks on eCTD submissions (hyperlinking, bookmarking, validation).
  • Maintain electronic document management and publishing systems.
  • Stay up-to-date with evolving global regulatory requirements and timelines.

Skills

Communication skills
Interpersonal skills
Critical thinking
Detail oriented
Organization

Education

Bachelor's degree in relevant field

Tools

Veeva RIM

Job description

ORIC Pharmaceuticals is seeking an experienced Regulatory Operations Specialist in San Diego to maintain records of regulatory submissions and health authority correspondence. You will support electronic publishing of regulatory submissions and ensure documentation is complete and compliant.

The role requires 1–3 years in regulatory affairs, familiarity with RIM systems (e.g., Veeva RIM), and strong communication skills. On-site base salary ranges from $80,000 to $90,000 per year.

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