Job Description Summary
Plan, coordinate, evaluate, follow-up, execute and implement pharmaceutical regulatory and technical activities, to obtain and maintain Marketing Authorizations (MA) of Sandoz products and ensure business continuity, in compliance with the goals set by the company and current local regulation in the markets of Central America and Caribbean (CAC).
Job Description
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.
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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 with HAs and analyses and prepares responses to the Letters of Authority Questions (LoAQ) during product registration and lifecycle.
Tracks and communicates regulatory relevant activities and commitments, approvals, deadlines, events and KPIs for assigned