Regulatory Dossier & AI Enablement Lead

Praxy; Ciudad de México; Híbrido; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb is seeking a Regulatory Tactical Manager in Mexico City to convert strategy into executable tactical plans, manage submission calendars, and guide third parties in local regulatory processes.

The role emphasizes hands‑on dossier work, AI and automation adoption, and cross‑functional coordination with Marketing, Medical, Legal and Quality to ensure compliant, timely filings.

Formación

• 4–6 years of experience in Regulatory Affairs with hands‑on dossier work.
• Knowledge of COFEPRIS and CTD/eCTD standards.
• Experience guiding external partners or CMOs on regulatory documents.
• Strong project management and organizational skills.

Responsabilidades

• Own day‑to‑day governance mechanics and project trackers for the portfolio.
• Provide dossier compilation support and third‑party guidance to ensure timely submissions.
• Translate regulatory strategy into detailed tactical plans and timelines.
• Oversee AI and digital enablement within regulatory workflows.
• Coordinate cross‑functional activities across Regulatory, Marketing, Medical, Legal and Quality.
• Share best practices and mentor junior analysts in tactical planning and execution.

Conocimientos

Regulatory affairs

Dossier compilation

PM certification

AI/digital tooling

Cross-functional coordination

Technical communication

Leadership

Educación

Bachelor's in Life Sciences

Descripción del empleo

Bristol Myers Squibb is seeking a Regulatory Tactical Manager in Mexico City to convert strategy into executable tactical plans, manage submission calendars, and guide third parties in local regulatory processes.

The role emphasizes hands‑on dossier work, AI and automation adoption, and cross‑functional coordination with Marketing, Medical, Legal and Quality to ensure compliant, timely filings.