Teva
Teva

Regulatory Affairs Associate

The Regulatory Affairs Associate III is a project manager (PM) responsible for new registrations for Teva own developed products, for achieving Marketing Authorization (MA) for the Medis business.The PM is either assigned to specific products or markets.The PM is responsible for planning, preparing and/or submitting Marketing Authorization Applications (MAAs) to regulatory authorities and/or Medis clients.

Menntunar- og hæfniskröfur
BSc/MSc required preferably in pharmaceutical sciences
Experience in regulatory affairs is preferred
Excellent organizational skills
Excellent communication and presentation skills
Excellent written and verbal knowledge in English
Strategic thinking and flexibility to adapt to changes
Strong team player
Good computer skills
Helstu verkefni og ábyrgð
EU/EEA markets: Plan, prepare and submit MAA to health authorities (DCP/MRP/National) or third party clients.
International markets (non-EU): Provide Medis clients with support for MAA submissions.
Coordinate and contribute to the response to deficiency from health authorities and act as key contact between R&D, Site RA, Clinical team, Medis clients and other functions as relevant.
Monitor timelines and coordinate relevant flow of information to internal and/or external contacts during the registrations process until end of procedure or MA approval.
Define CPP strategy and screening of Teva´s MAs for international markets.
Ensure the most up to date regulatory dossier is provided by working closely with the Harlow team and relevant site RA teams. Consolidate the dossier from eCTD sequences if not available in “master” format.
Provide regulatory guidance/support to Medis.
Database updates and other document management systems/lists.
Work on other specialised projects as defined by managers of Medis RA.
Organise audit of dossiers and due diligence to clients.
Regular status updates to management.
Auglýsing birt21. júlí 2022
UmsóknarfresturEnginn
Tungumálahæfni
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Staðsetning
Dalshraun 1, 220 Hafnarfjörður
Starfstegund
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