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
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
SKILLS NEEDED TO BE SUCCESSFUL
14+ years of experience spanning regulatory affairs and/or compliance in biotech or pharma
Hands-on experience with FDA submissions and agency interactions; international regulatory experience a plus
Experience with GDPR compliance, privacy program development, and data protection governance — including DPIAs, Records of Processing Activities, breach management, and privacy-by-design implementation
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 HAVE (BUT NOT REQUIRED)
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
What We Offer
Absci offers highly competitive salaries and benefits, including medical, dental, vision insurance, unlimited vacation, parental leave, employee assistance program, voluntary life and disability insurance, annual bonus potential, and 401(k) with a generous company match.
Equal Opportunity Statement
Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Legal authorization to work in the United States is required.
Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which they have applied should make a request to the recruiter or hiring manager, or contact hiring@absci.com.
