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| Global Regulatory Leader / EU Partner |
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Within a team of Regulatory Professionals in the Program Management Group, based either at headquarters in Basle, Switzerland, or our large R&D site in Welwyn, UK, you will be responsible for providing strategic advice and proactive regulatory input to the internal functions for the management of products under development, and managing the EU (or global) registration procedures. You will represent Regulatory Affairs at relevant products teams meetings. You will be leading the interactions with the regulatory agencies.
You represent the function on cross-functional teams (Product Teams/Lifecycle Team).
You manage the registration procedures globally or in EU (National, Centralised or Mutual Recognition) and ROW.
You take the lead in the interaction with alternatively regulatory agencies during product lifecycle management
You prepare regulatory submissions in collaboration with the other disciplines.
You coordinate core dossiers for CTAs.
You prepare integrated plans relating to the regulatory submissions or specific functional projects.
You answer questions from authorities and subsidiaries. |
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Bachelors (scientific / technical discipline)
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7 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Home Counties |
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You should have a University degree, preferably in a scientific / technical discipline.
You should also have several years experience in International Regulatory Affairs, a good knowledge of regulatory processes, especially in the EU. For the Global Regulatory Leader role you should have at least a vast experience in Global Drug Regulatory Affairs.
Working knowledge of core processes in discovery, development, manufacturing and marketing is also required.
Good communication, interpersonal skills and good knowledge of English and the ability to work in a team-based environment is essential. |
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Roche is the world's largest biotech company, global market leader for in-vitro diagnostics and cancer & transplantation drugs. |
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