Regulatory Affairs Lead: Biosimilars & Global Compliance

Sandoz; Ciudad de México; Presencial; MXN 300.000 - 540.000; Jornada completa

Descripción de la vacante

Sandoz in Mexico City is seeking a Regulatory Affairs professional to support submission of product registrations, progress reports, and safety updates, ensuring compliance with local regulations. You will maintain licenses, coordinate NP4/KRPIA guidelines, and liaise with internal and external stakeholders to advance registration activities.

The role emphasizes timely reporting of adverse events, management of labeling, packaging materials, and collaborations across cross-cultural teams in a

Formación

• Cross-cultural experience across diverse teams.
• Experience in operations management and execution.
• Project management skills with ability to manage timelines.
• Functional breadth across regulatory or lifecycle activities.

Responsabilidades

• Achieve best product registration with attractive labelling per plan.
• Maintain product licenses with CMC/ CDS updates per local guidelines.
• Ensure NP4, KRPIA compliance for CPO activities (DRAGON update, RMP, packing, PMS).
• Foster relations with internal and external stakeholders.
• Report technical complaints, adverse events, or special cases within 24 hours.
• Distribute marketing samples where applicable.

Conocimientos

Analytical Skill

Clinical Trials

Collaboration

Detail Oriented

Lifesciences

Project Planning

Regulatory Compliance

Descripción del empleo

Sandoz in Mexico City is seeking a Regulatory Affairs professional to support submission of product registrations, progress reports, and safety updates, ensuring compliance with local regulations. You will maintain licenses, coordinate NP4/KRPIA guidelines, and liaise with internal and external stakeholders to advance registration activities.

The role emphasizes timely reporting of adverse events, management of labeling, packaging materials, and collaborations across cross-cultural teams in a