Manager - Senior Compliance Manager

Company Description

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. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. For more information, please go to

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We are seeking an experienced 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. Manage the preparation and coordination of submissions to INDs or CTAs (including EU CTIS submissions and country-specific applications in regions outside the U.Prepare and deliver high-quality and timely regulatory submissions include all required documents and are compliant with applicable regulatory requirements.
Contribute to strategic planning for assigned programs by providing regulatory guidance on U.Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
Develop, manage and track regulatory submission timelines.
Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams.
Review investigator packages and support site start-up activities from regulatory perspective.
Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively 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.
Bachelor’s degree in a scientific or related field, advanced degree preferred (MS, PhD, PharmD).
~12 years experience with Bachelors degree -or- 8 years experience and Masters degree -or- 5 years experience and PhD/PharmD
~ Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests).
~ Strong project management skills and organization skills, with ability to work independently, manage multiple projects simultaneously, and meet deadlines in a lean, fast-paced environment.
~ Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (eg, investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
~ A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape.
~ Familiarity with global regulatory requirements and guidelines (FDA, ICH), with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things.
~ Computer expertise, including Microsoft Office Suite proficiency (eg, 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

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.
Regulatory