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Swiss regulatory affairs specialist

Basel
Brenntag
Inserat online seit: 1 April
Beschreibung

*Your Role**
Working in a Pharma team, you will be supporting the EMEA divisions on topics around the supply of raw materials into the pharmaceutical industry including regulatory, legal, compliance, quality and product safety
*Responsibilities** *Responsibilities**
Your responsibilities will bei
Completion of technical and regulatory documentation and information requests from customers for supply of raw materials into the pharmaceutical industry (questionnaires, supply chain agreements, quality agreement and technical agreements) in and English. Sourcing information internally and from suppliers to satisfy customer requests. Reporting and documenting customer requests via KPIs. Collaborating with commercial and value-added services teams, proactively leading and managing regulatory topics related to customer projects. Collaborating with QHSE & supply chain teams to ensure regulatory compliance and support with current standards and implementation of new standards (IPEC GMP/GDP, EXCiPACT, GDP etc). Collaborating within the Pharma Regulatory team on global business unit projects. Creation and management of product regulatory information in standardized format. Providing training on regulatory relevant topics to commercial and supply chain team. Any other tasks within capability to support the commercial success of the Pharma business unit. *Your Profile**
You will have
A degree or considerable experience in life sciences. Knowledge of pharmaceutical industry requirements and regulations on APIs, excipients, biopharma, and traditional pharma raw materials. Knowledge of Swiss Medic and other European National Competent Authority requirements for distribution of APIs, Excipients, and raw materials to the pharmaceutical industry. Fluent in English & German/Swiss German (speaking and written). You are a good collaborator & effective communicator with the ability

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