Regulatory Affairs Officer

For our Pfizer office in Bratislava, Slovakia we are looking for a Regulatory Officer.

This is what you can look forward to: Management of the new registrations, license maintenance and related activities for the assigned products under the supervision of the Head of Regulatory Affairs Eastern Europe Sub-Cluster. Be accountable for the regulatory compliance within the area of responsibilities.

Your responsibilities will include:
* Preparation of Marketing Authorization (MA) applications, renewals, variations and related activities: Collate, coordinate, create the necessary technical data to support the submission of new MA applications, renewals and variations for the assigned products
* Support the European wide application process for the assigned products, clarifying the requirements and ensuring local needs are met
* Inform the relevant internal stakeholders about the regulatory authority's approval of changes to the packaging component(s) for the assigned products
* Link with the Product Quality Manager for timely implementation of the approved labelling-associated artworks
* Handling with all relevant global databases and systems and other applications
* Monitor the progress of applications against the set timelines
* Provide support for local inspections as defined by the Regulatory Inspection Site Action Plan
* Professional interaction and expertise communication with external (Health Authority inquiries) and internal stakeholders

In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture.