Senior Regulatory Affairs Manager

ORIC Pharmaceuticals•South San Francisco, CA

8h•$175,000 - $200,000

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, clinical, and internal and CRO teams to prepare and coordinate high-quality, timely, compliant regulatory submissions. It contributes regulatory guidance and strategic planning for assigned programs across U.S., EU CTIS, and country-specific CTA processes, while managing submission preparation, timelines, health authority correspondence, and regulatory intelligence. The position also supports investigator packages and site start-up, contributes to SOP development and review, and performs duties in accordance with company values, policies, and applicable regulations. The anticipated salary range is $175,000–$200,000 in South San Francisco. This position is not eligible for H-1B visa sponsorship.

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, with 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 quickly acquire knowledge in 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 with a can-do attitude.

Nice To Haves

Advanced degree (MS, PhD, or PharmD) preferred.
Experience with 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 high-quality, timely regulatory submissions that include required documents and comply with applicable regulatory requirements.
Provide regulatory guidance on U.S., EU CTIS, and country-specific CTA processes to support strategic planning for assigned programs.
Create, assemble, review, and archive complex regulatory submissions, coordinating 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 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 values, policies, and applicable regulations.