Director, Regulatory & Compliance

Absci Corp.; United States; Remote; USD 180.000 - 260.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental insurance

Vision insurance

Unlimited vacation

Parental leave

401(k) with company match

Employee assistance program

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory leadership

FDA submissions

Regulatory strategy

Cross-functional collaboration

Ausbildung

Bachelor's degree in science or law

Advanced degree preferred (JD/MS/PharmD)

Jobbeschreibung

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.

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

SKILLS NEEDED TO BE SUCCESSFUL

• 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 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 [e-mail].