Regulatory Affairs Specialist (Insurgentes de Pueblo Yaqui)

Regulatory Affairs Specialist (Insurgentes de Pueblo Yaqui)

12 ago
|
Sandoz México
|
Insurgentes de Pueblo Yaqui

12 ago

Sandoz México

Insurgentes de Pueblo Yaqui

Main Responsibilities
Regulatory intelligence and regulatory environment
- Understands the local and international regulatory environment and processes.
- Provides regulatory expertise and knowledge regarding local and international regulations.
- Follows up new legislation discussions with trade associations and Health Authorities (HAs).
- Monitors national changes in regulation by continuous education on regulatory issues and keeping up with – and communicating to other functions – changes and trends within the local and international regulatory environment which are likely to affect Sandoz’ interests.
- undefined

Main Responsibilities
Regulatory intelligence and regulatory environment
- Understands the local and international regulatory environment and processes.
- Provides regulatory expertise and knowledge regarding local and international regulations.
- Follows up new legislation discussions with trade associations and Health Authorities (HAs).




- Monitors national changes in regulation by continuous education on regulatory issues and keeping up with – and communicating to other functions – changes and trends within the local and international regulatory environment which are likely to affect Sandoz’ interests.
- undefined

Operational excellence
- Works in team to prepare, execute, and define regulatory strategies for the registration of products.
- Provides technical evaluation of legal, technical, scientific, and clinical documents for dossier preparation.
- Compiles and prepares regulatory documentation for regulatory submissions with precision to support portfolio growth, effective launches, and business continuity.
- Responsible for regulatory maintenance activities, such as CMC changes, supply-limiting changes, safety label changes, MA renewals, and other related life-cycle management tasks.
- Prepares bioequivalence dossiers for submission to CAC HAs, as per local requirements, and follows-up the respective approval and maintenance processes.
- Liaises

📌 Regulatory Affairs Specialist (Insurgentes de Pueblo Yaqui)
🏢 Sandoz México
📍 Insurgentes de Pueblo Yaqui

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