Senior Regulatory Affairs Manager

ORIC Pharmaceuticals•San Diego, CA

13h•$165,000 - $175,000

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, and clinical teams to deliver high-quality, timely regulatory submissions. It combines strategic regulatory guidance with hands-on submission planning and execution across U.S., EU CTIS, and other country-specific CTA processes. The position is responsible for coordinating, preparing, assembling, reviewing, and archiving complex regulatory submissions and related documents; managing submission timelines and health authority correspondence; supporting investigator packages and site start-up; monitoring and communicating regulatory intelligence; and contributing to SOP development. The role requires effective collaboration with internal teams and CROs and attention to applicable regulatory requirements, company policies, and core values.

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 simultaneously, 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 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 with a can-do attitude.

Nice To Haves

Advanced degree (MS, PhD, or PharmD) preferred.
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 that comply with applicable requirements.
Provide regulatory guidance on U.S., EU CTIS, and country-specific CTA processes for assigned programs.
Create, assemble, review, and archive complex regulatory submissions in collaboration 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.