Strategic Regulatory Affairs Lead – Oncology

Regulatory Jobs; San Diego (CA); Presencial; USD 120.000 - 210.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory submissions

IND/DSUR/CTA

Communication skills

Project management

Attention to detail

Editorial/writing

Cross-functional collaboration

Regulatory intelligence

Educación

Bachelor's degree in sciences

Advanced degree preferred

Herramientas

Veeva RIM

Microsoft Office Suite

Descripción del empleo

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.