ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. Backed by Correlation Ventures.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree in a scientific or related field, advanced degree preferred (MS, PhD, PharmD)
- 12 years experience with Bachelor's degree -or- 8 years experience and Master's degree -or- 5 years experience and PhD/PharmD
- Demonstrated hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, outside the U.S. CTA preparation and coordination, and health authority interactions and response management
- Experience managing IND and CTA lifestyle activities (amendments, updates, and maintenance)
- Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests)
- Strong communication, interpersonal, and collaboration skills across internal and external stakeholders
More about this role
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. 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.
- Manage the preparation and coordination of submissions to INDs or CTAs (including EU CTIS submissions and country-specific applications in regions outside the U.S.)
- 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.S., EU CTIS, and country specific CTA processes
- Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory...
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