Senior Regulatory Affairs Leader, Oncology Submissions

ORIC Pharmaceuticals; San Diego (CA); On-site; USD 165,000 - 175,000; Full time

Job summary

ORIC Pharmaceuticals, a clinical stage biopharmaceutical company in San Diego, seeks an experienced Regulatory Affairs professional to advance oncology product development. You will collaborate across regulatory operations, quality, CMC, nonclinical and clinical teams to support timely regulatory submissions and ensure compliance.

The role requires hands-on IND and CTA experience, strong writing and project management skills, and the ability to balance strategic thinking with execution in a

Qualifications

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• 12 years experience with Bachelor's or 8 years with MS or 5 years with PhD/PharmD.
• Experience with U.S. IND submissions, EU CTIS, outside-the-US CTAs and health authority interactions.
• Strong writing, communication and collaboration across stakeholders.

Responsibilities

• Coordinate IND/CTA submissions and country-specific applications.
• Prepare high-quality regulatory submissions and documents for compliance.
• Provide regulatory guidance for US, EU CTIS, and country CTA processes.
• Develop, manage and track regulatory submission timelines and archives.
• Collaborate with regulatory operations, quality, CMC, nonclinical and clinical teams.
• Ensure submissions meet standards of accuracy and completeness.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Project management

Attention to detail

Writing/editing

Education

Bachelor's degree in a scientific field

Advanced degree preferred (MS/PhD/PharmD)

Tools

Veeva RIM

Microsoft Office

Job description

ORIC Pharmaceuticals, a clinical stage biopharmaceutical company in San Diego, seeks an experienced Regulatory Affairs professional to advance oncology product development. You will collaborate across regulatory operations, quality, CMC, nonclinical and clinical teams to support timely regulatory submissions and ensure compliance.

The role requires hands-on IND and CTA experience, strong writing and project management skills, and the ability to balance strategic thinking with execution in a