Regulatory Operations Specialist

Regulatory Toolkit; San Diego (CA); Sur place; USD 80 000 - 90 000; Plein temps

Résumé du poste

ORIC Pharmaceuticals, a clinical-stage biopharmaceutical company, seeks an experienced Regulatory Operations Specialist in San Diego to maintain regulatory records and support electronic publishing of submissions. You will ensure documentation is complete, traceable, and compliant with health authority standards.

Responsibilities include archiving US and ex-US submissions, tracking interactions in RIM, publishing eCTD submissions, and performing QA checks.

Qualifications

• 1–3 years of industry experience in regulatory affairs.
• BS degree in a related field or equivalent.
• Experience with regulatory submissions processes and systems.
• Strong communication and attention to detail.

Responsabilités

• Archive regulatory submissions (US and ex-US) with version control.
• Own the tracking of health authority interactions in a Regulatory Information Management system.
• Publish submissions using eCTD publishing software and submit to health authorities (FDA ESG).
• Assist publishing of documents (nonclinical reports, clinical study reports, Investigator's Brochure) using MS Word and PDF tools.
• Perform quality control checks on eCTD submissions and ensure conformance to specs.
• Support maintenance of electronic document management and publishing systems.
• Stay up-to-date with evolving global regulatory requirements and timelines.

Connaissances

Regulatory submissions

Communication

Attention to detail

Cross-functional collaboration

Formation

BS degree in relevant field

Outils

Veeva RIM

eCTD publishing tools

Description du poste

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.

We are seeking an experienced Regulatory Operations Specialist with a proven record of achievement and innovation. The Regulatory Operations Specialist is responsible for maintaining accurate records of regulatory submissions, health authority correspondence, as well as supporting the electronic publishing of regulatory submissions. This role ensures the organization's regulatory documentation is complete, traceable, and compliant with health authority and internal standards.

• Perform archiving of regulatory submissions (US and ex-US) and health authority correspondence, ensuring that documents are version-controlled and retrievable.
• Own the tracking of health authority interactions and responses in a Regulatory Information Management system.
• Perform submission publishing using eCTD publishing software and submit to health authorities (e.g., FDA Electronic Submission Gateway [ESG]).
• Support document publishing on various documents (including but not limited to nonclinical reports, clinical study reports, Investigator's Brochure) 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.
• Stay up-to-date with evolving global regulatory requirements, guidelines, and industry trends that could impact regulatory submissions and approval timelines.

Perform all duties in keeping with the Company's core values, policies and all applicable regulations.

• 1-3 years industry experience in industry-related position. BS Degree in relevant field (or equivalent).
• Experience supporting regulatory affairs processes and systems for clinical and commercial activities.
• Knowledge and hands on experience using Regulatory Information Management systems (e.g., Veeva RIM) or regulatory submission publishing systems is a plus.
• Effective oral and written communication skills. Strong interpersonal skills. Ability to successfully solve challenging issues, perform critical thinking, and be detail oriented.

Excellent organizational ability - can easily multitask and shift priorities as needed.

The anticipated base salary for candidates who will work on-site at our San Diego location is between $80,000-$90,000 per year. The final rate offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.This position is not eligible for H-1B visa sponsorship.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.