Senior Regulatory Affairs Manager - Oncology Submissions

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 oncology product development.

You will collaborate with regulatory operations, quality, CMC, nonclinical and clinical teams to support timely submissions and provide strategic regulatory guidance across US, EU CTIS, and other regions. The role entails coordinating IND/CTA submissions, ensuring compliance with regulatory requirements, maintaining submission timelines, and communicating regulatory

Qualifications

• Bachelor’s degree in a scientific or related field; advanced degree preferred.
• 12 years experience with Bachelor's degree -or- 8 years experience and Master's degree -or- 5 years experience and PhD/PharmD.
• Demonstrated hands‑on experience with U.S. IND submissions, EU CTA submissions in CTIS, outside the U.S. CTA preparation and coordination, and health authority interactions and response management
• Experience managing IND and CTA lifecycle activities (amendments, updates, and maintenance)
• Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests).
• Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.

Responsibilities

• Manage the preparation and coordination of submissions to INDs or CTAs (including EU CTIS submissions and country-specific applications in regions outside the U.S.)
• Prepare and deliver high-quality and timely regulatory submissions include all required documents and are compliant with applicable regulatory requirements.
• Contribute to strategic planning for assigned programs by providing regulatory guidance on U.S., EU CTIS, and country specific CTA processes
• 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 which require interaction with internal and CRO teams to ensure optimal execution.
• Develop, manage and track regulatory submission timelines.
• Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, 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 regulatory perspective.
• Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally.
• Contribute to the development and review of standard operating procedures to ensure regulatory compliance.

Skills

Regulatory submissions

Cross-functional collaboration

Project management

Regulatory intelligence

Excellent writing & editing

Communication skills

Education

Bachelor’s degree in a scientific or related field

Advanced degree preferred (MS, PhD, PharmD)

Tools

Veeva RIM

Microsoft Office

Job description

ORIC Pharmaceuticals, Inc. is seeking an experienced Regulatory Affairs professional to advance oncology product development.

You will collaborate with regulatory operations, quality, CMC, nonclinical and clinical teams to support timely submissions and provide strategic regulatory guidance across US, EU CTIS, and other regions. The role entails coordinating IND/CTA submissions, ensuring compliance with regulatory requirements, maintaining submission timelines, and communicating regulatory