Regulatory Operations Lead: AI-Enabled Dossier & Strategy

Bristol-Myers Squibb Co; Ciudad de México; Híbrido; MXN 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb in Mexico is seeking a Regulatory Tactical Manager to translate approved strategy into executable plans, manage dossier assembly, and guide third parties to timely local submissions. This role drives AI-enabled tooling adoption and cross-functional coordination across Regulatory, Marketing, Legal and Quality.

You will own the regulatory calendar, ensure data integrity across systems, and develop team capabilities while supporting country-level governance.

Formación

• Bachelor degree in Life Sciences or related field.
• 4-6 years in Regulatory Affairs with hands-on dossier work.
• Knowledge of COFEPRIS requirements and CTD/eCTD standards.
• PM experience; PMP/CAPM a plus.
• Experience guiding external partners (distributors/CMOs).

Responsabilidades

• Coordinate project and portfolio governance for regulatory filings.
• Provide dossier technical execution and guidance to third parties.
• Plan tactical calendars for registrations, variations, renewals.
• Lead AI-enabled tools adoption within regulatory workflows.
• Coordinate cross-functional timelines with Regulatory, Marketing, Legal and Quality.
• Mentor analysts and share best practices.

Conocimientos

Regulatory affairs

Dossier compilation

Project management

AI/digital tools

Cross-functional coordination

Educación

Bachelor's degree in Life Sciences

Herramientas

CTD/eCTD standards

AI-enabled tools

Dossier management systems

Descripción del empleo

Bristol Myers Squibb in Mexico is seeking a Regulatory Tactical Manager to translate approved strategy into executable plans, manage dossier assembly, and guide third parties to timely local submissions. This role drives AI-enabled tooling adoption and cross-functional coordination across Regulatory, Marketing, Legal and Quality.

You will own the regulatory calendar, ensure data integrity across systems, and develop team capabilities while supporting country-level governance.