Regulatory Affairs Manager

Regulatory Jobs; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

ORIC Pharmaceuticals in South San Francisco, CA is seeking a Regulatory Affairs professional to advance oncology programs. You will collaborate with regulatory operations, quality, CMC, nonclinical, and clinical teams to support high-quality regulatory submissions and strategic planning.

The ideal candidate has a scientific background, 6–8 years in regulatory affairs, experience preparing IND/DSUR/CTA, and strong writing, communication, and project management skills to navigate global regulatory

Qualifications

• Bachelor’s degree in a scientific or related field; advanced degree preferred.
• 6–8 years regulatory affairs experience in pharma/biotech, or a combination of advanced degree and regulatory experience.
• Experience preparing regulatory submissions (IND, DSUR, CTA, FDA meeting requests).
• Strong writing, editorial, and communication skills across internal/external stakeholders.

Responsibilities

• Support regulatory submissions and contribute to strategic planning for assigned programs.
• Prepare and deliver high-quality regulatory submissions compliant with applicable regulatory requirements.
• Create, assemble, review, and archive complex regulatory submissions with internal and CRO teams.
• Develop, manage and track regulatory submission timelines.
• Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, and clinical teams.
• Ensure submissions meet 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 and regulatory intelligence.
• Contribute to the development and review of SOPs to ensure regulatory compliance.
• Perform all duties in keeping with company values and regulations.
• Familiarity with FDA/ICH guidelines and global regulatory requirements.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Project management

Communication skills

Attention to detail

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Tools

Veeva RIM

Job 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) 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.