Director, Regulatory & Compliance

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $195k - $240k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

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Absci

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci is a biotechnology company that uses generative artificial intelligence together with wet-lab validation to design de novo biologics, primarily antibodies. Its integrated AI Drug Creation Platform performs data generation, model training, de novo design, multi-parametric lead optimization, and AI-enabled target discovery (using reverse immunology) to uncover novel antibody/target pairs and accelerate IND-enabling studies. Absci advances internal and partnered therapeutic programs—such as ABS-201, a designed antibody targeting prolactin receptors for androgenetic alopecia—and emphasizes rapid iterative cycles between AI and lab work to shorten biologics discovery timelines.

📋 Description

• Build and maintain the company's ethics and compliance program, including policies, training, monitoring, and reporting mechanisms • Develop and execute regulatory strategy across the product development and commercial lifecycle, focusing on FDA and applicable international authorities such as EMA and ICH • Monitor evolving regulatory and legislative landscapes, including AI/ML guidance, data privacy law, and biotech-specific frameworks, and assess business impact • Serve as primary liaison for regulatory agency interactions, submissions, and inspections • Lead internal investigations and audits, and manage corrective action and remediation processes • Develop and implement a GDPR-ready data governance framework, including DPIAs, ROPAs, and data subject rights mechanisms • Establish privacy-by-design principles across product and platform development with Engineering and Product teams • Ensure privacy governance structures across jurisdictions where Absci operates or processes personal data • Lead vendor and third-party data protection due diligence, including DPAs and sub-processor compliance • Maintain incident response and breach management protocols satisfying GDPR's 72-hour notification window • Report regulatory, compliance, privacy program status, and GDPR readiness metrics to the CLO, Board, or external stakeholders • Collaborate with Legal, Quality, IT, and Clinical teams to embed compliance into business operations

🎯 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 • Comfortable operating without a large team; a builder and self-starter who thrives in a fast-paced environment • Strong communication skills, including translating regulatory complexity for non-specialist stakeholders and 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 is nice to have • Familiarity with AI/ML in drug discovery regulatory considerations is nice to have • Government affairs or policy engagement experience is nice to have • Legal authorization to work in the United States is required

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Unlimited vacation • Parental leave • Employee assistance program • Voluntary life insurance • Voluntary disability insurance • Annual bonus potential • 401(k) with a generous company match • Equity