Director, Regulatory Affairs (labeling, Advertising And Promotion)

Arrowhead Pharmaceuticals, Inc.

Pasadena, United States
Base: $210,000 - $230,000 usd; bonus/equity: not s...
On-site
Global regulatory labeling strategy
Promotional review and practices
Fda office of prescription drug promotion (opdp)
Arrowhead Pharmaceuticals is seeking a Director of Regulatory Affairs, focusing on labeling and promotional activities, to lead the global regulatory labeling strategy for their product pipeline. The role involves managing regulatory compliance in labeling and advertising, requiring extensive experience in regulatory affairs within the pharmaceutical or biotechnology sectors

Job Summary

  • The Director provides strategic and operational leadership for regulatory labeling and promotional activities, managing global regulatory labeling strategy through all phases of development and post-approval.
  • Responsibilities include ensuring promotional review and practices are consistent with regulatory requirements, providing guidance on US promotional campaigns, and serving as the regulatory lead on the US Promotional Review Committee.
  • Arrowhead provides competitive salaries and an excellent benefit package, with a California pay range of $210,000 - $230,000 USD.

Matching Summary

Match Score: 85

Arrowhead Pharmaceuticals is seeking a Director of Regulatory Affairs, focusing on labeling and promotional activities, to lead the global regulatory labeling strategy for their product pipeline. The role involves managing regulatory compliance in labeling and advertising, requiring extensive experience in regulatory affairs within the pharmaceutical or biotechnology sectors.

Salary

Base: $210,000 - $230,000 USD; Bonus/Equity: Not specified; Benefits: Excellent benefit package

Skills & Requirements

Must-have

  • global regulatory labeling strategy
  • promotional review and practices
  • FDA Office of Prescription Drug Promotion (OPDP)
  • Advertising and Promotion Labeling Branch (APLB)
  • US promotional materials submissions (FDA 2253)

Nice-to-have

  • nimble, science-driven innovators
  • collaboration with Commercial, Medical Affairs, and Legal
  • emerging technologies, including AI applications

Key Requirements

  • Bachelor’s degree in life sciences
  • 10+ years of relevant experience
  • Leadership experience in Regulatory Affairs Operations
  • Deep expertise in electronic submission requirements (eCTD)
  • Authorization to work in the US

Work Rights

Authorization to work in the US

Tailored Resume

Cover Letter