Regulatory Affairs Manager

Regulatory Affairs Manager

We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC, nonclinical and clinical functions to support high-quality, timely regulatory submissions. The ideal candidate is a proactive team player who thrives in cross-functional environments, communicates effectively, and can balance strategic thinking with strong execution.

Essential duties and responsibilities include the following. Other duties may be assigned.

1. Support regulatory submissions and contribute to strategic planning for assigned programs.
2. Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
3. Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
4. Develop, manage and track regulatory submission timelines.
5. Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams.
6. Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives.
7. Review investigator packages and support site start-up activities from regulatory perspective.
8. Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally.
9. Contribute to the development and review of standard operating procedures to ensure regulatory compliance.

Perform all duties in keeping with the Company's core values, policies and all applicable regulations.

The anticipated salary range for candidates is between $145,000-$165,000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. This position is not eligible for H-1B visa sponsorship.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.

ORIC Pharmaceuticals Inc.