AI Regulatory Affairs Consultant

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

A life sciences sponsor with an active clinical pipeline is looking for a senior Regulatory Affairs Consultant to design and stand up an AI-enabled platform for regulatory documentation and submissions. The goal is to substantially cut authoring, review, and submission-assembly time without compromising compliance, traceability, or inspection readiness.

This role blends regulatory and AI expertise. The consultant must know regulatory submissions deeply enough to define what “right” looks like, and understand AI well enough to build, validate, and govern tools that get there faster. AI drafts and checks; qualified people review and approve. Human oversight stays built into every step.

Key Responsibilities

Platform strategy and design

• Assess current regulatory processes (IND/CTA, NDA/BLA/MAA, amendments, annual reports, safety reports) and identify where AI delivers the biggest time savings
• Define the 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, investigator brochures, CSRs, and briefing documents from source data and templates
• Build automated quality checks: cross-document consistency, data-to-text verification, reference and hyperlink validation, and eCTD technical conformance
• Design retrieval-augmented generation (RAG) over prior submissions, agency correspondence, and guidance documents so outputs are grounded and cited
• Set up submission readiness tracking: required documents, owners, review status, and deadlines

Compliance, validation, and governance

• Validate the platform under GxP and CSV/CSA principles, including 21 CFR Part 11 and EU Annex 11
• Establish an AI governance framework: human-in-the-loop review, audit trails, model change control, data privacy, and accuracy monitoring
• Align the approach with current FDA and EMA expectations on AI use, and with the EU AI Act where applicable

Adoption and handover

• Train regulatory, medical writing, and clinical teams on new workflows and SOPs
• Define and report on success metrics (cycle time, review rounds, QC findings, first-pass technical acceptance)
• Document the platform and transfer ownership to the internal team

Required 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

Preferred Qualifications

• Advanced degree (PhD, PharmD, MS) or RAC certification
• Has delivered an AI-assisted submission or regulatory writing platform from pilot to production
• Technical depth in prompt engineering, RAG, LLM output evaluation, or Python-based automation
• Familiarity with structured content authoring (SCA), IDMP, and ePI standards
• Experience across multiple health authorities (FDA, EMA, MHRA, PMDA, Health Canada)
• Exposure to CDISC SDTM/ADaM for data-to-document automation
• Background in change management for large regulatory or medical writing teams