Director, Regulatory & Compliance

Absci

8d•$195,000 - $240,000

About The Position

Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio), and YouTube. Absci believes regulatory and compliance is the framework that lets us move fast and do right by patients. We are hiring a hands-on regulatory and compliance leader to build and own the function from the ground up with a focus on future patients. This is a broad, high-impact role for someone who has operated across both regulatory affairs and compliance programs and who is energized by the variety that comes with a growing, mission-driven organization. This role will be the company's primary subject matter expert on regulatory strategy, ethics and compliance programs, and government affairs, partnering closely with the CLO and CMO to shape how we operate in a regulated environment. The level (Director vs. Senior Director) will be determined based on the experience and scope the right candidate brings.

Requirements

14+ years of experience spanning regulatory affairs and/or compliance in biotech, pharma, or a related regulated industry
Hands-on experience with FDA submissions and agency interactions; international regulatory experience a plus
Ability to build or significantly scale a compliance program rather than just maintain one
Comfortable operating without a large team; a builder and self-starter who thrives in a fast-paced environment
Strong communicator who can translate regulatory complexity for non-specialist stakeholders, including executives
Bachelor's degree in a scientific or legal discipline; advanced degree (JD, MS, PharmD) preferred

Nice To Haves

Experience in a clinical-stage or early-commercial biotech environment
Familiarity with AI/ML in drug discovery regulatory considerations
Government affairs or policy engagement experience

Responsibilities

Build and maintain the company's ethics and compliance program, including policies, training, monitoring, and reporting mechanisms; ensure the program reflects current regulatory expectations and evolving best practices
Develop and execute regulatory strategy across the product development and commercial lifecycle, with a focus on FDA and applicable international authorities (EMA, ICH)
Monitor the evolving regulatory and legislative landscape — including updates to AI/ML guidance, data privacy law, and biotech-specific frameworks — and assess business impact across the organization
Build and maintain the company's ethics and compliance program, including policies, training, monitoring, and reporting mechanisms
Serve as primary liaison for regulatory agency interactions, submissions, and inspections — representing Absci with confidence and credibility
Monitor the evolving regulatory landscape and assess business impact
Lead internal investigations and audits; manage corrective action and remediation processes
Develop and implement a GDPR-ready data governance framework, including data protection impact assessments (DPIAs), records of processing activities (ROPAs), and data subject rights mechanisms (access, erasure, portability, objection) aligned with EU and UK GDPR requirements
Establish and maintain privacy-by-design principles across product and platform development, working with Engineering and Product teams to ensure personal data handling is minimized, documented, and auditable from the outset
Ensure appropriate privacy governance structures are in place in all jurisdictions where Absci operates or processes personal data
Lead vendor and third-party due diligence on data protection matters, including negotiation of Data Processing Agreements (DPAs) and oversight of sub-processor compliance under applicable privacy regulations
Maintain incident response and breach management protocols that satisfy GDPR's 72-hour notification window and coordinate with Legal and IT Security on investigation, containment, and regulatory notification
Report on regulatory and compliance matters — including privacy program status and GDPR readiness metrics — to the CLO and, as needed, to the Board or external stakeholders
Collaborate cross-functionally with Legal, Quality, IT and Clinical teams to embed compliance into business operations
Report on regulatory and compliance matters to the CLO and, as needed, to the Board or external stakeholders