Director of Regulatory Strategy & Compliance

Absci Corp.; United States; Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Unlimited vacation

Parental leave

401(k) with company match

Employee assistance program

Job summary

Absci Corp. is seeking a hands-on Regulatory and Compliance leader to establish and own the function, partnering with the CLO and CMO to navigate FDA and international regulatory landscapes.

This is a high-impact role at a growing biotech company focused on ethical AI-driven drug creation. The successful candidate will build programs, manage investigations and audits, and implement privacy-by-design across product development, ensuring compliance across jurisdictions and with data protection

Qualifications

• 14+ years of regulatory affairs and/or compliance experience in biotech/pharma or related fields.
• Hands-on experience with FDA submissions and agency interactions; international regulatory experience a plus.
• Experience building or significantly scaling a compliance program.
• Strong communicator who can translate regulatory complexity for executives.

Responsibilities

• Build and maintain ethics and compliance program with policies, training, monitoring, and reporting.
• Develop and execute regulatory strategy across product development and lifecycle (FDA and international authorities).
• Lead regulatory interactions, submissions, and inspections as primary liaison.
• Establish GDPR-ready data governance and privacy-by-design across product and platform development.
• Collaborate with Legal, Quality, IT and Clinical teams to embed compliance into operations.

Skills

Regulatory leadership

FDA submissions

Regulatory strategy

Cross-functional collaboration

Education

Bachelor's degree in science or law

Advanced degree preferred (JD/MS/PharmD)

Job description

Absci Corp. is seeking a hands-on Regulatory and Compliance leader to establish and own the function, partnering with the CLO and CMO to navigate FDA and international regulatory landscapes.

This is a high-impact role at a growing biotech company focused on ethical AI-driven drug creation. The successful candidate will build programs, manage investigations and audits, and implement privacy-by-design across product development, ensuring compliance across jurisdictions and with data protection