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丹麦 药理学 药剂师管理

 

简要信息

 

工作

Regulatory Affairs Pharmacist

主要研究领域

Pharmacological sciences

工作内容

Do you want to make a difference? Our mission is to make medicine accessible. We will do that by providing good service, delivering products at the right time and through reasonable pricing. We are a leading generic pharmaceutical company which means that you as employee have the chance to work with many different challenging tasks. Our size means that you will not disappear in the crowd and that you get the possibility for personal development and room to take responsibility. Make a difference! Alpharma´s ambition is to become the leading supplier of API´s and End−to−End solutions for the injectable market by offering all key API´s as finished product solutions in a Business−to−Business concept. Alpharma´s strategy is to double the number of API products in five years and actively develop finished product injectable formulations and dossiers for key API´s and target marketing authorizations in both US, Europe and in the rest of the world. As part of this aggressive growth strategy we are seeking one Regulatory Affairs Pharmacist. Regulatory Affairs Pharmacist You will form part of an international and well established regulatory team of 10 people with a high activity level. You will report to the manager of Regulatory Affairs and also work closely with the Director of Portfolio Management and Regulatory Affairs. Your responsibility will be to ensure regulatory compliance of Alpharma´s API´s and on a global basis to provide regulatory support to API customers to ensure that they obtain and maintain product approvals. The position will initially be for 1 year with the possibility of prolongation.

工作描述

The Job: The main areas of responsibility will be: Preparation of new EU DMF, US DMF, CEP applications and regulatory documentation to individual countries world wide Maintenance of the above documentation and ensure that our files comply with current regulatory requirements Preparing responses to the regulatory authorities Answering of customer inquiries Participation in project groups Keeping up to date with current scientific knowledge and regulatory requirements Qualifications: Pharmacist with minimum 1 years of experience with Regulatory Affairs Good English language skills and able to understand Norwegian Must be able to acquire and maintain a broad knowledge of the entire process/production flow Must be able to work in a multi cultural environment with different types of people Good knowledge of current guidelines Structured and efficient Pro−active with a positive attitude The Company offers: An exciting and challenging job in a growing, global company. Unique, career−building experience A global Alpharma network. Competitive compensation and flexible schedule. Contact: Send your application in English and detailed CV marked "Regulatory Affairs Pharmacist" to our HR department no later than 31.05.2006. For further information please contact the above mentioned persons. Visit www.alpharma.com to read more about Alpharma.

合同形式

Permanent

工作制度

Full-time

国家

DENMARK

城市

København

公司/研究院

Alpharma ApS

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