Senior Regulatory Affairs Manager

ORIC Pharmaceuticals•San Diego, CA

About The Position

ORIC Pharmaceuticals is seeking an experienced Regulatory Affairs professional to support the clinical development of oncology products. The role collaborates with regulatory operations, quality, CMC, nonclinical, and clinical colleagues to deliver high-quality, timely regulatory submissions. The successful candidate is a proactive team player who communicates effectively, works across functions, and balances strategic planning with hands-on execution. The position manages preparation, coordination, review, assembly, and archival of IND and CTA submissions, including EU CTIS and country-specific applications outside the U.S. It provides regulatory guidance for assigned programs, oversees submission timelines, supports investigator packages and site start-up, maintains health authority correspondence archives, and contributes to regulatory intelligence and standard operating procedures. The role requires strong organization and project management skills in a lean, fast-paced environment. The anticipated salary range is $165,000–$175,000 in San Diego. The final offer depends on factors including title, experience, industry experience, and education. This position is not eligible for H-1B visa sponsorship. ORIC Pharmaceuticals is an equal opportunity employer.

Requirements

Bachelor’s degree in a scientific or related field.
12 years of experience with a bachelor’s degree, or 8 years with a master’s degree, or 5 years with a PhD or PharmD.
Hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, CTA preparation and coordination outside the U.S., and health authority interactions and response management.
Experience managing IND and CTA lifecycle activities, including amendments, updates, and maintenance.
Experience preparing regulatory submissions such as INDs, DSURs, CTAs, and FDA meeting requests.
Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
Strong project management and organizational skills, including the ability to work independently, manage multiple projects, and meet deadlines in a lean, fast-paced environment.
High attention to detail and excellent problem-solving and analytical thinking abilities.
Excellent writing and editorial skills, including the ability to develop clinical-regulatory documents such as investigator brochures, briefing documents, IND amendments, and Fast Track or ODD designation requests.
Strong scientific background and ability to learn therapeutic areas and the evolving regulatory landscape.
Familiarity with global regulatory requirements and guidelines, including FDA and ICH, and ability to gather and analyze regulatory intelligence.
Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
Flexible, proactive, hands-on mindset and can-do attitude.

Nice To Haves

Advanced degree preferred (MS, PhD, or PharmD).
Experience with a regulatory information management system such as Veeva RIM.

Responsibilities

Manage preparation and coordination of IND and CTA submissions, including EU CTIS submissions and country-specific applications outside the U.S.
Prepare and deliver complete, high-quality, timely regulatory submissions compliant with applicable requirements.
Contribute regulatory guidance and strategic planning for assigned programs, including U.S., EU CTIS, and country-specific CTA processes.
Create, assemble, review, and archive complex regulatory submissions in coordination with internal and CRO teams.
Develop, manage, and track regulatory submission timelines.
Collaborate with regulatory operations, quality, CMC, nonclinical, and clinical teams.
Ensure submissions are accurate, complete, and consistent, 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, and communicate regulatory intelligence internally.
Contribute to the development and review of standard operating procedures to ensure regulatory compliance.
Perform duties in accordance with company core values, policies, and applicable regulations.