Director, Regulatory & Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and sustain the organization's ethics and compliance program, encompassing policies, training, monitoring, and reporting mechanisms.

• Formulate and implement regulatory strategies throughout the product development and commercial lifecycle, with an emphasis on FDA and relevant international authorities such as EMA and ICH.

• Keep abreast of evolving regulatory and legislative landscapes, including guidance on AI/ML, data privacy laws, and biotech-specific frameworks, while evaluating business implications.

• Act as the primary point of contact for regulatory agency interactions, submissions, and inspections.

• Oversee internal investigations and audits, while managing corrective action and remediation processes.

• Create and enforce a GDPR-compliant data governance framework, which includes DPIAs, ROPAs, and mechanisms for data subject rights.

• Implement privacy-by-design principles in collaboration with Engineering and Product teams throughout product and platform development.

• Ensure the establishment of privacy governance structures in all jurisdictions where Absci operates or processes personal data.

• Lead the due diligence process for vendor and third-party data protection, including DPAs and compliance of sub-processors.

• Maintain protocols for incident response and breach management that comply with GDPR's 72-hour notification requirement.

• Provide updates on regulatory compliance, privacy program status, and GDPR readiness metrics to the CLO, Board, and external stakeholders.

• Work in partnership with Legal, Quality, IT, and Clinical teams to integrate compliance into business operations.

⛳️ Requirements

• A minimum of 14 years of experience in regulatory affairs and/or compliance within the biotech, pharmaceutical, or a similar regulated industry.

• Practical experience with FDA submissions and interactions; international regulatory experience is advantageous.

• Proven ability to build or significantly enhance a compliance program.

• Comfortable working independently without a large team; a self-starter who excels in a dynamic environment.

• Excellent communication skills, including the ability to convey regulatory complexities to non-specialist stakeholders and executives.

• Bachelor's degree in a scientific or legal field; an advanced degree (JD, MS, PharmD) is preferred.

• Experience in a clinical-stage or early-commercial biotech setting is a plus.

• Familiarity with AI/ML regulatory considerations in drug discovery is a bonus.

• Experience in government affairs or policy engagement is desirable.

• Legal authorization to work in the United States is mandatory.

🏝️ 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