Base: $280,000 - $320,000 usd; bonus/equity: not s...
On-site
10+ years regulated drug environment experience
Management experience in regulatory affairs
Expertise in us and ex-us clinical regulations
Arrowhead Pharmaceuticals is seeking an Executive Director of Regulatory Affairs to lead clinical regulatory submissions for their drug development pipeline, with a focus on compliance and collaboration with health authorities. The role requires extensive experience in regulatory affairs within the pharmaceutical industry and mandates a presence in Pasadena or San Diego, California
Job Summary
Arrowhead Pharmaceuticals is a commercial stage biopharmaceutical company developing medicines that treat intractable diseases by silencing genes using RNA interference technology.
The Executive Director will lead the Clinical Regulatory sub-team, providing global oversight for submissions across the entire pipeline with a focus on the EU.
This role requires onsite presence 5 days a week in either Pasadena or San Diego, California, with a preference for Pasadena.
Matching Summary
Match Score: 85
Arrowhead Pharmaceuticals is seeking an Executive Director of Regulatory Affairs to lead clinical regulatory submissions for their drug development pipeline, with a focus on compliance and collaboration with health authorities. The role requires extensive experience in regulatory affairs within the pharmaceutical industry and mandates a presence in Pasadena or San Diego, California.
Salary
Base: $280,000 - $320,000 USD; Bonus/Equity: Not specified; Benefits: Excellent benefit package included
Skills & Requirements
Must-have
10+ years regulated drug environment experience
Management experience in regulatory affairs
Expertise in US and ex-US clinical regulations
Track record of successful IND and registrational filings
Oversight of global clinical regulatory submissions
Nice-to-have
Experience leading major regulatory agency interactions
Proficiency with Veeva RIM System or equivalent
Background in RNA interference therapeutics
Experience bringing projects to commercialization
Key Requirements
Bachelor of Science degree (advanced degree preferred)
10+ years relevant experience in regulated drug environment
Valid authorization to work in the United States
Work Rights
Must have current, valid authorization to work in the country where this role is located