Regulatory Affairs Manager

Regulatory Toolkit; San Diego (CA); Sur place; USD 120 000 - 210 000; Plein temps

Résumé du poste

ORIC Pharmaceuticals, a clinical stage biopharmaceutical company in San Diego, seeks a Regulatory Affairs professional to support high-quality regulatory submissions and cross-functional collaboration across regulatory operations, quality, CMC, nonclinical, and clinical teams.

The ideal candidate has 6–8 years of regulatory experience, strong writing and editorial skills, and a solid scientific background to navigate FDA/ICH guidelines and global requirements.

Qualifications

• Bachelor’s degree in a scientific field required.
• Preferred 6–8 years of regulatory affairs experience in pharma/biotech.
• Experience preparing regulatory submissions (IND, DSUR, CTA, FDA meeting requests).
• Strong communication, interpersonal, and collaboration skills across stakeholders.
• Good project management skills with ability to manage multiple projects and meet deadlines.
• High attention to detail with strong analytical thinking.
• Excellent writing and editorial skills for clinical-regulatory documents.
• Strong scientific background and ability to learn regulatory landscape.

Responsabilités

• Support regulatory submissions and contribute to strategic planning for assigned programs.
• Prepare and deliver high-quality regulatory submissions in compliance with requirements.
• Create, assemble, review, and archive complex submissions with internal and CRO teams.
• Develop, manage, and track regulatory submission timelines.
• Collaborate with regulatory operations, quality, CMC, nonclinical, and clinical teams.
• Ensure submissions meet standards for accuracy and maintain archives.
• Review investigator packages and support site start-up activities from a regulatory perspective.
• Analyze current regulatory issues and communicate regulatory intelligence internally.
• Contribute to development and review of SOPs to ensure compliance.
• Perform duties in line with company values and applicable regulations.

Connaissances

Regulatory submissions

IND/DSUR/CTA

Communication skills

Project management

Attention to detail

Editorial/writing

Cross-functional collaboration

Regulatory intelligence

Formation

Bachelor's degree in sciences

Advanced degree preferred

Outils

Veeva RIM

Microsoft Office Suite

Description du poste

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) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, 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.ORIC has offices in South San Francisco and San Diego, California.

We are seeking a motivated 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. The ideal candidate is a proactive team player who thrives in cross-functional environments, communicates effectively, and can balance strategic thinking with strong execution.

Essential duties and responsibilities include the following. Other duties may be assigned.

Support regulatory submissions and contribute to strategic planning for assigned programs.

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.

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 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.

Preferred minimum 6-8 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, or a combination of an advanced degree and regulatory experience.

Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests).

Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.

Good project management skills; able to manage multiple projects simultaneously and meet deadlines.

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 (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.