Strategic Regulatory Lead, Oncology Submissions

ORIC Pharmaceuticals, Inc.; San Diego (CA); Sur place; USD 165 000 - 175 000; Plein temps

Résumé du poste

ORIC Pharmaceuticals, Inc. is seeking an experienced Regulatory Affairs professional to advance oncology product registrations.

You will collaborate across regulatory operations, quality, CMC, nonclinical and clinical teams to ensure timely, high-quality submissions and strategic guidance for U.S., EU CTIS and country-specific programs. The role requires a proactive, cross-functional team player with excellent writing and project management skills, based in San Diego, with a salary range of

Qualifications

• Bachelor’s degree in a scientific or related field; advanced degree preferred (MS, PhD, PharmD).
• 12 years with Bachelor’s or 8 years with MS or 5 years with PhD/PharmD.
• Experience with U.S. IND submissions, EU CTA submissions in CTIS, and outside-US CTA coordination.

Responsabilités

• Manage preparation and coordination of IND/CTA submissions (EU CTIS and country-specific).
• Prepare high-quality regulatory submissions complying with requirements.
• Provide strategic regulatory guidance for US, EU CTIS, and country CTA processes.

Connaissances

IND submissions

Regulatory submissions

Cross-functional collaboration

Project management

Scientific writing

Formation

Bachelor’s degree in a scientific field

MS/PhD/PharmD preferred

Outils

Veeva RIM

Description du poste

ORIC Pharmaceuticals, Inc. is seeking an experienced Regulatory Affairs professional to advance oncology product registrations.

You will collaborate across regulatory operations, quality, CMC, nonclinical and clinical teams to ensure timely, high-quality submissions and strategic guidance for U.S., EU CTIS and country-specific programs. The role requires a proactive, cross-functional team player with excellent writing and project management skills, based in San Diego, with a salary range of