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| Regional Manager in Regulatory Affairs |
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# Manages and has command of all regulatory activities for a specific country region including information on requirements, legislations, oversight on regulatory environment
# Is the primary contact for affiliates requests and questions to filter and triage at corporate level and is responsible for knowledge sharing of Region specific regulatory environment
# Coordinates Common Technical Dossier activities in for NME’s and their respective variations as well as renewals for our marketed products
# Works in close collaboration with the Key Country Partner to prepare and provide to affiliates all regulatory documents required for a given submission
# Interacts with other functions within and outside of PDR to ensure that affiliates requirements are met to fulfil our business needs
# Supports, monitors and tracks affiliates submissions and approvals for all applications (including new registrations, new indications, renewals etc.)
# Organizes regular group meetings with affiliates to ensure effective communication of key messages and travels to affiliates as needed. |
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Bachelors Degree
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10 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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Basel |
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* University Degree, preferably in life science discipline
* 10 years’ experience in regulatory affairs
* Proven successful experience in international regulatory affairs is valued
* Knowledge and experience of global regulatory processes
* Fluency in written and spoken English
* Ability to solve complex problems, excellent communication and negotiation skills.
Contact HR: V. Gkiokas, Phone: +4161 6882072. Job ID: 00385193 |
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At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site. |
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Roche (F. Hoffmann-La Roche AG)
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