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We have a new Global Regulatory Affairs Specialist with one of the leading pharma companies in Malta. Reporting to the Senior Manager based in the US, you will be responsible for the following:
Understanding the technology used to support all aspects of the submission and publishing process
Supporting the assembly, review and technical approval for regulatory dossiers and documents for assigned products
Identifying appropriate resources needed to support submission activities
Supporting submission team in planning, scheduling, coordinating and executing regulatory submission development
Report submission updates within defined timelines against milestones and define risks which could affect submission timeline
Support submission content/format to ensure high quality submissions to Regulatory Authorities.
We have a new Global Regulatory Affairs Specialist with one of the leading pharma companies in Malta. Reporting to the Senior Manager based in the US, you will be responsible for the following:
Understanding the technology used to support all aspects of the submission and publishing process
Supporting the assembly, review and technical approval for regulatory dossiers and documents for assigned products
Identifying appropriate resources needed to support submission activities
Supporting submission team in planning, scheduling, coordinating and executing regulatory submission development
Report submission updates within defined timelines against milestones and define risks which could affect submission timeline
Support submission content/format to ensure high quality submissions to Regulatory Authorities.