
Teva
Teva Pharmaceuticals
Who we are
Our mission is to be a global leader in generics and biopharmaceuticals, improving the lives of patients across the world.
In a complex world, Teva's mission is simple: to improve the lives of patients across the globe. We believe that everyone should have access to quality medicines whether it be for managing disease, fighting infections, or simply improving overall health.
We are proud that since Teva’s establishment in 1901, healthcare providers together with patients and caregivers have been using our accessible generic and innovative products. Today, our portfolio of around 3,600 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of Teva's quality medicines every day. We invest in research and development of generic medicines and biopharmaceuticals, carrying on the legacy of more than a century of finding new ways to help patients improve their lives. This defines our values as a company and characterizes how we do business and approach medicine.
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
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
Engar sérstakar tungumálakröfur
Staðsetning
Dalshraun 1, 220 Hafnarfjörður
Starfstegund
Vinnuumhverfi
Starfsgreinar
Starfsmerkingar
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