Senior Regulatory Submissions Lead, Oncology

ORIC Pharmaceuticals Inc.; South San Francisco (CA); On-site; USD 175,000 - 200,000; Full time

Job summary

ORIC Pharmaceuticals Inc. is seeking an experienced Regulatory Affairs professional to advance clinical oncology programs. You will partner with regulatory operations, quality, CMC, nonclinical and clinical teams to deliver timely submissions and maintain archives.

The role emphasizes cross-functional collaboration, effective communication, and balancing strategic thinking with rigorous execution in a fast-paced environment.

Qualifications

• Experience with U.S. IND submissions and EU CTA submissions.
• Strong regulatory writing and documentation skills.
• Ability to manage multiple submissions and timelines.

Responsibilities

• Manage preparation and coordination of IND/CTA submissions.
• Prepare and deliver high-quality regulatory submissions in compliance with requirements.
• Provide regulatory guidance across US, EU CTIS and country CTAs.
• Create, assemble, review, and archive complex submissions with internal/CRO teams.
• Develop and track regulatory submission timelines.
• Collaborate with regulatory operations, quality, CMC, nonclinical and clinical teams.
• Ensure accuracy, completeness, and consistency of submissions.

Skills

Strong communication skills

Project management

Attention to detail

Editorial/writing skills

Independent work ability

Analytical thinking

Team collaboration

Education

Bachelor’s degree in a scientific or related field

MS/PhD/PharmD preferred

Tools

Veeva RIM

Microsoft Office

Job description

ORIC Pharmaceuticals Inc. is seeking an experienced Regulatory Affairs professional to advance clinical oncology programs. You will partner with regulatory operations, quality, CMC, nonclinical and clinical teams to deliver timely submissions and maintain archives.

The role emphasizes cross-functional collaboration, effective communication, and balancing strategic thinking with rigorous execution in a fast-paced environment.