Regulatory Affairs Tactical & AI Manager
Core
Operational engine for the Mexico regulatory function, converting strategy into executable tactical plans and managing day-to-day project governance for pharmaceutical submissions.
Role type
Senior IC Regulatory Affairs Manager (Mexico)
Builds
Executable tactical plans, dossier compilations, and AI-enabled regulatory workflows for the Mexico market.
Domain
Pharmaceuticals / Regulatory Affairs / Mexico
Required skills
Regulatory dossier compilation, COFEPRIS/eCTD standards, project governance, third-party vendor management, tactical planning, AI tool adoption, cross-functional coordination
Preferred skills
PMP/CAPM certification, experience guiding external partners/distributors, piloting automation in regulatory workflows
Technologies
BMS RIM, eCTD, COFEPRIS systems, AI-enabled drafting and QC tools
Responsibilities
Operate day-to-day governance mechanics (trackers, dashboards, escalation logs) for the assigned portfolio; provide hands-on technical compilation support for dossiers (new registrations, renewals, variations); guide third parties on format and documentation completeness; translate regulatory strategy into detailed tactical project plans and submission calendars; administer AI-enabled tools for regulatory intelligence and submission quality checks; coordinate cross-functional dependencies for promotional materials and labeling.
Seniority
Mid-Senior, hands-on IC
