Regulatory Affairs Lead – Oncology Submissions

Regulatory Jobs; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

ORIC Pharmaceuticals in South San Francisco, CA is seeking a Regulatory Affairs professional to advance oncology programs. You will collaborate with regulatory operations, quality, CMC, nonclinical, and clinical teams to support high-quality regulatory submissions and strategic planning.

The ideal candidate has a scientific background, 6–8 years in regulatory affairs, experience preparing IND/DSUR/CTA, and strong writing, communication, and project management skills to navigate global regulatory

Qualifications

• Bachelor’s degree in a scientific or related field; advanced degree preferred.
• 6–8 years regulatory affairs experience in pharma/biotech, or a combination of advanced degree and regulatory experience.
• Experience preparing regulatory submissions (IND, DSUR, CTA, FDA meeting requests).
• Strong writing, editorial, and communication skills across internal/external stakeholders.

Responsibilities

• Support regulatory submissions and contribute to strategic planning for assigned programs.
• Prepare and deliver high-quality regulatory submissions compliant with applicable regulatory requirements.
• Create, assemble, review, and archive complex regulatory submissions 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 accuracy, completeness, and consistency, and maintain health authority correspondence archives.
• Review investigator packages and support site start-up activities from regulatory perspective.
• Expand knowledge by analyzing current regulatory issues and regulatory intelligence.
• Contribute to the development and review of SOPs to ensure regulatory compliance.
• Perform all duties in keeping with company values and regulations.
• Familiarity with FDA/ICH guidelines and global regulatory requirements.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Project management

Communication skills

Attention to detail

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Tools

Veeva RIM

Job description

ORIC Pharmaceuticals in South San Francisco, CA is seeking a Regulatory Affairs professional to advance oncology programs. You will collaborate with regulatory operations, quality, CMC, nonclinical, and clinical teams to support high-quality regulatory submissions and strategic planning.

The ideal candidate has a scientific background, 6–8 years in regulatory affairs, experience preparing IND/DSUR/CTA, and strong writing, communication, and project management skills to navigate global regulatory