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About the Role

ORIC Pharmaceuticals is seeking a motivated Regulatory Affairs professional to support the clinical development of oncology products. This role involves close collaboration with various internal teams to ensure high-quality, timely regulatory submissions. The ideal candidate is a proactive team player with strong communication skills and the ability to balance strategic thinking with execution.

Responsibilities

• Support regulatory submissions and contribute to strategic planning for assigned programs.
• Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
• Responsible for the creation, assembly, review, and archival of complex regulatory submissions, interacting with internal and CRO teams.
• Develop, manage, and track regulatory submission timelines.
• Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, and clinical teams.
• Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives.
• Review investigator packages and support site start-up activities from a regulatory perspective.
• Analyze current regulatory issues, guidance, and initiatives, and effectively communicate regulatory intelligence internally.
• Contribute to the development and review of standard operating procedures to ensure regulatory compliance.
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Requirements

• Bachelor’s degree in a scientific or related field.
• Experience in preparing regulatory submissions (e.g., IND, DSUR, CTA, FDA meeting requests).
• Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
• Good project management skills; able to manage multiple projects simultaneously and meet deadlines.
• High attention to detail, with excellent problem-solving and analytical thinking abilities.
• Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (e.g., investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
• A strong scientific background with the ability to quickly acquire knowledge in therapeutic areas and the evolving regulatory landscape.
• Familiarity with global regulatory requirements and guidelines (FDA, ICH).
• Ability to gather and analyze latest regulatory intelligence.
• Motivated to learn new things.
• Computer expertise, including Microsoft Office Suite proficiency (e.g., Word, Excel, PowerPoint).
• Experience with regulatory information management system (Veeva RIM) is a plus.

Skills

• Communication
• Interpersonal skills
• Collaboration
• Project management
• Problem-solving
• Analytical thinking
• Writing
• Editorial skills
• Scientific background
• Regulatory intelligence analysis
• Microsoft Office Suite proficiency
• Veeva RIM (preferred)

Location

• South San Francisco, California

Work Type

• Full-time

Experience Level

• 6-8 years of regulatory affairs experience in the pharmaceutical or biotechnology industry (preferred)
• Combination of an advanced degree and regulatory experience

Education Level

• Bachelor’s degree in a scientific or related field
• Advanced degree preferred

Salary/Compensations

• $160,000-$185,000

About the Company

• 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) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers.
• ORIC has offices in South San Francisco and San Diego, California.

Equal Opportunity

• 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 characteristic.