Associate Director, Regulatory Affairs Cmc

Gilead Sciences

California, United States
$182,070.00 - $235,620.00; bonus/equity: discretio...
Define regulatory strategy
Global approvals
Cmc regulatory guidelines
At Gilead, we’re creating a healthier world for all people by tackling diseases such as HIV, viral hepatitis, COVID-19 and cancer

Job Summary

  • At Gilead, we’re creating a healthier world for all people by tackling diseases such as HIV, viral hepatitis, COVID-19 and cancer.
  • As an Associate Director, CMC Regulatory Affairs for Biologics, you will be responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio.
  • The salary range for this position is: $182,070.00 - $235,620.00, and this position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

Matching Summary

At Gilead, we’re creating a healthier world for all people by tackling diseases such as HIV, viral hepatitis, COVID-19 and cancer.

Salary

$182,070.00 - $235,620.00; Bonus/Equity: Discretionary annual bonus, discretionary stock-based long-term incentives; Benefits: Paid time off, company-sponsored medical, dental, vision, and life insurance plans

Skills & Requirements

Must-have

  • define regulatory strategy
  • global approvals
  • CMC regulatory guidelines
  • Pharmaceutical Development & Manufacturing
  • Health Authority interaction
  • global CMC regulatory strategy

Nice-to-have

  • create inclusion
  • develop talent
  • empower teams
  • industry network
  • positive image of Gilead

Key Requirements

  • 10+ years of experience
  • Bachelor’s Degree
  • Advanced degrees including PhD and MS desired
  • Direct experience working with regional chemistry reviewers
  • Regulatory Affairs Certification, a plus
  • Previous management experience, a plus

Work Rights

Not specified

Tailored Resume

Cover Letter