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About the Role
ORIC Pharmaceuticals is seeking an experienced Regulatory Affairs professional to support the clinical development of oncology products. This role involves close collaboration with cross-functional teams to ensure high-quality and timely regulatory submissions.
Responsibilities
- Manage the preparation and coordination of submissions to INDs or CTAs, including EU CTIS submissions and country-specific applications outside the U.S.
- Prepare and deliver high-quality, timely regulatory submissions compliant with applicable regulatory requirements.
- Contribute to strategic planning by providing regulatory guidance on U.S., EU CTIS, and country-specific CTA processes.
- Responsible for the creation, assembly, review, and archival of complex regulatory submissions, interacting with internal and CRO teams.
- Develop, manage, and track regulatory submission timelines.
- Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, and 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 a regulatory perspective.
- Analyze current regulatory issues, guidance, and initiatives to expand knowledge and communicate regulatory intelligence internally.
- 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.
Requirements
- Demonstrated hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, and outside the U.S. CTA preparation and coordination.
- Experience managing IND and CTA lifecycle activities (amendments, updates, and maintenance).
- Experience in preparing regulatory submissions (e.g., IND, DSUR, CTA, FDA meeting requests).
- Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
- Strong project management and organization skills, with the ability to work independently, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment.
- High attention to detail, with excellent problem-solving and analytical thinking abilities.
- Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents.
- A strong scientific background with the ability to quickly acquire knowledge in therapeutic areas and the evolving regulatory landscape.
- Familiarity with global regulatory requirements and guidelines (FDA, ICH).
- Ability to gather and analyze latest regulatory intelligence and motivation to learn new things.
- Computer expertise, including Microsoft Office Suite proficiency (Word, Excel, PowerPoint).
- Experience with regulatory information management system (Veeva RIM) is a plus.
- Flexible, proactive, and hands-on mindset with a can-do attitude.
Skills
- Regulatory Affairs
- Oncology Product Development
- Regulatory Submissions (IND, CTA)
- EU CTIS
- Health Authority Interactions
- Project Management
- Communication
- Interpersonal Skills
- Collaboration
- Problem-Solving
- Analytical Thinking
- Writing
- Editorial Skills
- Scientific Background
- Global Regulatory Requirements (FDA, ICH)
- Regulatory Intelligence
- Microsoft Office Suite
- Veeva RIM (preferred)
Location
- South San Francisco, California
Work Type
- Full-time
Experience Level
- 12 years experience with Bachelor's degree
- 8 years experience with Master's degree
- 5 years experience with PhD/PharmD
Education Level
- Bachelor’s degree in a scientific or related field
- Advanced degree preferred (MS, PhD, PharmD)
Salary/Compensations
- $175,000-$200,000
About the Company
- ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer.
- ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers.
- ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms.
- ORIC has offices in South San Francisco and San Diego, California.
Equal Opportunity
- 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.