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Job description
Cullgen Inc. in San Diego seeks a senior Regulatory Affairs Consultant to lead regulatory strategy and global operations for early- and mid-stage programs. The role includes preparing INDs/CTAs/NDAs, coordinating with the FDA, and overseeing quality functions with GMP/GCP oversight to support product advancement.
You will guide external consultants, ensure SOP updates, and ensure compliance with US and international requirements, with onsite work at the San Diego office as needed.
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.