Regulatory Affairs Manager

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

This is what you can look forward to:

Management of the new registrations, license maintenance and related activities for the assigned products. Be accountable for the regulatory compliance within the area of responsibilities. Provision of regulatory advice to and liaison with key customers. Your responsibilities will include:

Preparation of Marketing Authorization applications, renewals, variations and related activities
Collate, coordinate and, where required, create the necessary technical data to support the submission of new Marketing Authorization applications, renewals and variations
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
Keep updated the local registration tracking of all new/ongoing applications, renewals and variations
Monitor the progress of applications against the set timelines, taking action when necessary
Contribution in managing Pfizer's relationship with the authorities
Provide support in the development, implementation and maintenance of the local procedures
Apply a risk management approach

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

Please apply in English documents only!