Regulatory Affairs Lead – Biosimilars & Generics

Sandoz México; Ciudad de México; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Sandoz México seeks a Regulatory Affairs professional to lead product registration efforts and ensure licenses remain compliant with CMC, CDS and safety updates across local regulations and global guidelines.

The role requires coordinating with internal teams and external stakeholders, managing timelines, and reporting adverse events promptly. Strong project management and cross-cultural experience are valued in this complex, global environment.

Formación

• Experience in regulatory affairs; ability to manage product licenses and updates in compliance with local regulations.
• Strong project management and cross-functional collaboration.
• Attention to detail and analytical mindset for safety and compliance.

Responsabilidades

• Achieve best product registration with commercially attractive labelling per registration plan.
• Maintain and secure product licenses including CMC/CDS/safety updates per local regulations and global compliance.
• Foster and maintain good relations with internal and external stakeholders; report adverse events within 24 hours.

Conocimientos

Regulatory compliance

Project management

Clinical trials

Analytics

Lifesciences

Detail oriented

Cross cultural experience

Descripción del empleo

Sandoz México seeks a Regulatory Affairs professional to lead product registration efforts and ensure licenses remain compliant with CMC, CDS and safety updates across local regulations and global guidelines.

The role requires coordinating with internal teams and external stakeholders, managing timelines, and reporting adverse events promptly. Strong project management and cross-cultural experience are valued in this complex, global environment.