Director of Regulatory

Position summary

At Regara, regulatory expertise is the product. The Director of Regulatory is the company's senior-most regulatory authority — Regara is not hiring a CRO at this stage — accountable for the accuracy, defensibility, and credibility of everything the platform produces. This is not a traditional compliance role: the Director sets the regulatory standard the platform is held to, shapes how the product reasons about FDA, EMA, PMDA, NMPA and other frameworks, leads Regara's regional regulatory affairs team directly, and is the company's most trusted regulatory voice with the professional community it serves.

Key responsibilities

• Own the regulatory soundness of Regara's outputs — the standards, corpus quality, predicate logic, and claim-traceability that determine whether generated content holds up under agency review.
• Define the regulatory quality bar and QA framework against which the platform's drafting, retrieval, and citation provenance are measured.
• Lead and develop Regara's regional regulatory affairs team — the regional Regulatory Managers and Specialists — and set consistent global standards across them.
• Partner with the AI, product, and engineering teams to encode regulatory reasoning correctly across submission types and jurisdictions.
• Serve as Regara's principal regulatory voice with customers, advisory boards, and the broader RA community.
• Represent Regara in industry forums on the appropriate, defensible use of AI in regulatory work.
• Advise leadership on the regulatory and policy landscape for AI-enabled tools in life sciences.
• Oversee Regara's own internal regulatory posture and partner with Legal on AI governance.

Qualifications

Required

• 10+ years in regulatory affairs within medical device, pharma, biologics, or IVD, including senior or lead responsibility.
• Deep, hands-on experience with submissions across FDA and ideally one or more of EMA, PMDA, NMPA.
• Authoritative command of submission pathways (510(k), De Novo, PMA, IND/NDA/BLA, IVDR) and the guidance ecosystem.
• Demonstrated ability to translate regulatory expertise into process, tooling, or systems.
• Strong external presence and credibility with regulatory professionals.
• Bachelor's in a life science, engineering, or related field.

Preferred

• Advanced degree (MS, PhD, PharmD, MD, or JD) and/or RAC certification.
• Experience with regulatory operations tooling and eCTD/eSTAR submissions.
• Prior experience at a high-growth software, AI, or regulatory-technology company.
• Experience building and leading a multi-region regulatory team.

What success looks like

Within the first year, the Director of Regulatory has established the quality standard the platform is measured against, deepened the defensibility of Regara's outputs across submission types and regions, built out and developed the regional RA team, and become a recognized, trusted regulatory voice that wins the confidence of the professionals Regara sells to.