Director, Global Regulatory Affairs

Protara Therapeutics

Remote
Base: $228,000 - $233,000; bonus/equity: incentive...
Remote
Ex-us regulatory strategy
Clinical study applications
Global submissions experience
Protara Therapeutics is seeking a Director of Global Regulatory Affairs to lead their ex-US regulatory strategy for clinical studies in oncology and rare diseases. The ideal candidate will have extensive regulatory experience, particularly in global submissions and interactions with health authorities, and will work remotely or in a hybrid model

Job Summary

  • Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases.
  • The Director, Global Regulatory Affairs leads Protara’s ex-US regulatory strategy and operational execution for Protara’s clinical studies in oncology, cell and gene therapy, and rare diseases.
  • We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

Matching Summary

Match Score: 85

Protara Therapeutics is seeking a Director of Global Regulatory Affairs to lead their ex-US regulatory strategy for clinical studies in oncology and rare diseases. The ideal candidate will have extensive regulatory experience, particularly in global submissions and interactions with health authorities, and will work remotely or in a hybrid model.

Salary

Base: $228,000 - $233,000; Bonus/Equity: incentive bonus, equity compensation; Benefits: matching 401(k), medical, dental, vision, commuter, and fertility benefits

Skills & Requirements

Must-have

  • ex-US regulatory strategy
  • clinical study applications
  • global submissions experience
  • lead IND/CTA submissions
  • resolve complex project issues
  • global pharmaceutical guidance

Nice-to-have

  • fast-paced biotech environment
  • first inhuman or first in class programs
  • rare disease natural history studies
  • patient focused drug development

Key Requirements

  • MD, Ph.D., or Pharm D. degree
  • Minimum 10 years pharmaceutical industry experience
  • At least 7 years regulatory experience
  • 8–12+ years regulatory affairs experience
  • Demonstrated success interacting with global health authorities
  • Hands-on experience leading IND submissions
  • Strong understanding of CMC, nonclinical, and clinical requirements

Work Rights

Not specified

Tailored Resume

Cover Letter