Director, Regulatory & Compliance

Absci · Remote

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Role summary

Absci seeks a Director of Regulatory & Compliance to build and lead the regulatory affairs and compliance function from the ground up. This role encompasses regulatory strategy, ethics and compliance programs, data privacy governance, and government affairs, reporting to the CLO and CMO. The level may be adjusted based on candidate experience.

What they're looking for

Extensive experience in both regulatory affairs and compliance programs
Demonstrated expertise in FDA and international regulatory strategy (EMA, ICH)
Strong knowledge of GDPR, data privacy law, and data protection frameworks
Experience leading ethics and compliance program development and implementation
Familiarity with biotech regulatory landscape and emerging AI/ML guidance
Track record managing regulatory agency interactions and submissions

What you'll be doing

Build and maintain ethics and compliance program including policies, training, and monitoring mechanisms
Develop and execute regulatory strategy across product development and commercial lifecycle
Serve as primary liaison for FDA and international regulatory agency interactions and submissions
Design and implement GDPR-ready data governance framework with DPIAs and privacy-by-design principles
Lead internal investigations, audits, and corrective action processes; manage breach response protocols

Privacy & handoff

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Date posted2 days ago

Last source check1 day ago

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