Job Description

Job Description

Regulatory Data Translator (Oncology, Immunology, Neurology)

Job Summary

We are hiring three Regulatory Data Translators to serve as the critical link between Regulatory Strategy and our Data & AI teams. These highly specialized roles enable the responsible use of Large Language Models (LLMs) and Generative AI (GenAI) on complex, unstructured regulatory data while maintaining the highest standards of compliance and governance.

Each role will be aligned to a high-priority Therapeutic Area (TA) — Oncology, Immunology, or Neurology — and will focus on translating regulatory needs into actionable, auditable data products. This position is ideal for a regulatory strategist who is deeply curious about data and AI and motivated to work hands-on at the intersection of compliance, technology, and innovation.

Key Responsibilities

1. Data Translation & Stakeholder Engagement

• Act as the primary translation layer between Regulatory Strategy and teams building data and AI products.
• Convert TA-specific regulatory needs into clear requirements for data product development.
• Communicate existing data products, AI model capabilities, and upcoming pipelines to key stakeholders, including Global Regulatory Leads.
• Maintain a strong understanding of regulatory “sources of truth” relevant to the assigned TA.

2. AI Governance & Risk Management (FDA-Aligned)

• Own AI governance activities within the assigned Therapeutic Area.
• Apply AI risk frameworks and conduct risk stratification for GenAI use cases in alignment with evolving FDA guidance.
• Ensure appropriate human-in-the-loop review for high-risk use cases impacting regulatory decisions, patient data, efficacy, or safety.

3. Data Product Management & Auditability

• Oversee the preparation of unstructured regulatory data (e.g., submissions, labels, correspondence) for LLM-enabled use cases.
• Ensure all AI outputs and data products are fully auditable, traceable back to source documents via metadata and vectorized text.
• Manage restricted regulatory data (including health authority submissions) with strict access controls and compliance standards.

Required Qualifications & Experience

Regulatory Expertise (Core Focus)

• 3–5 years of experience in Regulatory Strategy is required. This role balances strong regulatory judgment with hands-on involvement in AI-enabled solutions.
• Pharmaceutical industry experience strongly preferred, with demonstrated prioritization of compliance and quality.
• Prior experience supporting Oncology, Immunology, or Neurology, ideally as a North America regulatory lead, is highly desirable.

Data & Technology Fluency

• Strong interest in data, digital, and IT-enabled innovation.
• Working familiarity with Generative AI concepts and real-world use cases.
• Proven experience collaborating with IT or data teams on solution development (note: this is not a data science role).

Education

• Advanced degrees (e.g., Master’s, PhD, PharmD) are preferred and common in regulatory strategy, but relevant experience is valued over specific credentials.

Why This Role

This is a unique opportunity to shape how AI is responsibly applied in regulatory strategy—ensuring innovation moves forward without compromising compliance, patient safety, or auditability. If you thrive at the intersection of regulatory science, data, and emerging technology, this role was built for you.

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