AI-Driven Regulatory Affairs Architect

Confidential; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Confidential in the United States seeks a senior Regulatory Affairs Consultant to design and stand up an AI-enabled platform for regulatory documentation and submissions, aiming to cut authoring and review time while ensuring compliance, traceability, and inspection readiness.

The role blends regulatory and AI expertise: define what ‘right’ looks like, build and govern tools, ensure AI drafts are reviewed by qualified personnel, and keep human oversight built-in at every step.

Qualifications

• 10+ years in regulatory affairs or regulatory operations at a pharma, biotech, or CRO, with direct ownership of major submissions (IND, NDA/BLA, or MAA).
• Hands-on eCTD expertise: ICH M4 CTD structure, publishing, validation criteria, and agency gateways (FDA ESG, EMA CESP/IRIS).
• 2+ years leading AI or automation projects in a regulated setting (e.g., LLM-based authoring, NLP document review, intelligent automation).
• Working knowledge of GxP, CSV/CSA, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+).
• Experience with regulatory information management and document systems.
• Proven ability to translate regulatory requirements into technical specifications and work closely with engineers and vendors.
• Strong stakeholder management across regulatory, clinical, medical writing, quality, and IT.
• Bachelor’s degree in life sciences, pharmacy, engineering, or a related field.

Responsibilities

• Platform strategy and design: Assess current regulatory processes and identify where AI delivers the biggest time savings.
• Define target platform architecture: document authoring, structured content, RIM integration, eCTD publishing, and review workflows.
• Lead build-vs-buy decisions across leading RIM and AI platform vendors and custom LLM solutions.
• AI-enabled authoring and QC: Configure AI-assisted drafting of CTD Modules 2-5 content, protocols, investor brochures, CSRs, and briefing documents.
• Build automated quality checks: cross-document consistency, data-to-text verification, reference and hyperlink validation, and eCTD conformity.
• Design retrieval-augmented generation over prior submissions, agency correspondence, and guidance documents.
• Set up submission readiness tracking: required documents, owners, review status, and deadlines.
• Compliance, validation and governance: Validate under GxP and CSV/CSA, including 21 CFR Part 11 and EU Annex 11.
• Establish AI governance: human-in-the-loop review, audit trails, model change control, data privacy, accuracy monitoring.
• Adoption and handover: Train teams, define success metrics, document platform, and transfer ownership.

Job description

Confidential in the United States seeks a senior Regulatory Affairs Consultant to design and stand up an AI-enabled platform for regulatory documentation and submissions, aiming to cut authoring and review time while ensuring compliance, traceability, and inspection readiness.

The role blends regulatory and AI expertise: define what ‘right’ looks like, build and govern tools, ensure AI drafts are reviewed by qualified personnel, and keep human oversight built-in at every step.