Director, Global Regulatory Affairs

March 29

Nuvalent, Inc.

WebsiteLinkedInAll Job Openings

#PreciselyTargetedTherapies for patients with cancer

11 - 50

Description

• Newly created Director of Global Regulatory Affairs position at Nuvalent • Responsible for driving and implementing worldwide regulatory strategies and tactics across the development pipeline • Overseeing global development strategy and regulatory operations for respective program(s) • Managing development of clinical and regulatory documents for global submissions

Requirements

• S/M.S. in related field or related experience • 10+ years of work experience in a pharmaceutical/biotech regulatory affairs role • Advanced knowledge and experience in interpretation of regulations in the US and EU • Experience submitting INDs, NDAs/BLAs; ex-US CTAs and MAAs • Excellent verbal and written communication skills • Experience in a matrixed environment and small company environment • Ability to accommodate flexible working hours to support business relationships • Up to 10% domestic and international travel may be required • Experience working in oncology • Pediatric experience is a plus • Strong written/oral communication skills

Benefits

• Equal employment opportunities (EEO) • Flexible working hours • Up to 10% domestic and international travel may be required