absci - Director, Regulatory & Compliance
Requirements
• 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 • 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
Benefits
• 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 [email protected].
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