Director, Regulatory Affairs — Oncology Innovations

Regulatory Jobs; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

ORIC Pharmaceuticals is seeking a senior Regulatory Affairs professional to lead regulatory submissions for oncology programs. You will collaborate closely with regulatory operations, quality, CMC, nonclinical and clinical teams to ensure compliant, timely filings and strategic alignment with corporate goals.

The role requires 8+ years in regulatory affairs within pharma/biotech, with strong writing, communication, and leadership abilities to interact with FDA and global agencies.

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• 8+ years regulatory affairs experience in pharma/biotech.
• Experience preparing IND/DSUR/CTA and FDA meeting requests.
• Strong written and interpersonal communication with stakeholders.
• Ability to lead submissions and ensure regulatory compliance across programs.

Responsibilities

• Support regulatory submissions and provide strategic direction for development programs.
• Lead high-quality, timely regulatory submissions aligned with corporate goals and regulatory requirements.
• Coordinate regulatory activities across regulatory operations, quality, CMC, nonclinical and clinical teams.
• Create, assemble, review, and oversee complex regulatory submissions.
• Ensure submission completeness and adherence to standards.
• Represent ORIC with FDA and global regulatory agencies.
• Monitor regulatory issues and communicate intelligence internally.
• Provide strategic input on regulatory activities for product development plans.
• Develop and review SOPs to meet current regulatory requirements.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Excellent writing

Project management

Regulatory intelligence

Attention to detail

Communication skills

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Tools

Microsoft Word

Excel

PowerPoint

Job description

ORIC Pharmaceuticals is seeking a senior Regulatory Affairs professional to lead regulatory submissions for oncology programs. You will collaborate closely with regulatory operations, quality, CMC, nonclinical and clinical teams to ensure compliant, timely filings and strategic alignment with corporate goals.

The role requires 8+ years in regulatory affairs within pharma/biotech, with strong writing, communication, and leadership abilities to interact with FDA and global agencies.