Senior Global Regulatory Affairs Strategist

Posted yesterday

cullgenSan Diego (CA)

Regulatory Affairs Managers Pharmaceutical Preparation Manufacturing

SENIORITY

Manager

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About the role

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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