Regulatory Affairs Lead: Global Submissions & Compliance

MX16 (FCRS = MX016) Sandoz S.A. de C.V.; México; Presencial; MXN 600.000 - 1.100.000; Jornada completa

Descripción de la vacante

Sandoz Mexico S.A. de C.V. seeks a Regulatory Affairs professional to support submissions for product registrations, progress reports, supplements and periodic safety reports, ensuring compliance with local regulations.

The role requires cross-functional collaboration across internal and external stakeholders and timely regulatory activities. You will lead license maintenance, CMC updates, safety reporting, and alignment with NP4/KRPIA codes while supporting labeling and promotional material

Formación

• Work Experience: Functional Breadth. Cross Cultural Experience. Operations Management and Execution. Project Management.
• Skills: Analytical Skill. Clinical Trials. Collaboration. Detail Oriented. Lifesciences. Project Planning. Regulatory Compliance.
• Languages : English.

Responsabilidades

• Achieve the best product registration with commercially attractive labelling in accordance with registration plan
• Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance
• Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.)
• Foster and maintain good relations with internal and external stakeholders
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Conocimientos

Analytical Skill

Clinical Trials

Collaboration

Detail-Oriented

Lifesciences

Project Planning

Regulatory Compliance

Descripción del empleo

Sandoz Mexico S.A. de C.V. seeks a Regulatory Affairs professional to support submissions for product registrations, progress reports, supplements and periodic safety reports, ensuring compliance with local regulations.

The role requires cross-functional collaboration across internal and external stakeholders and timely regulatory activities. You will lead license maintenance, CMC updates, safety reporting, and alignment with NP4/KRPIA codes while supporting labeling and promotional material