PharmaRelations / Fresenius Kabi

Product Design Master – Regulatory Affairs

Fresenius Kabi is now looking to recruit a Product Design Master to the Regulatory Affairs department at the Business Unit Parenteral Nutrition, Colloids and Ketosteril. This is a newly created, permanent, full-time position based in Uppsala. The Product Design Master will report to the Director Regulatory Affairs PN & Ketosteril / Design Responsibility.
Upprättad
Ansökningsfrist
den 29 juli 2018
Förväntad start.
den 1 september 2018
Anställningsförhållanden
Fast
Antal timmar
Fulltid
Anställning
Fast
Region
Sverige > Alla regioner

What we do
The Business Unit Parenteral Nutrition, Colloids and Ketosteril manages the global product portfolio strategy including life cycle management and future pipeline development, such as product design, development and maintenance of the regulatory files. We manage the product portfolio strategy, profitability, forecast, strategic planning and execution. We are responsible for the communication of the core product’s brand positioning, communication and for global marketing campaigns. Furthermore, we provide scientific support to Global Operations and the Market Units/Regions.

Your responsibilities
You will be a key player in the regulatory change management process and responsible to manage activities and projects which have regulatory impact, using project management tools. In the role you will organize and facilitate cross-functional team meetings across international sites to exchange information; identify project risks and assess the feasibility of the proposed changes. Together with the team you will generate a complete assessment of the proposed change and communicate this to management. In some cases, you will also lead the project until the change has received regulatory approval.

What you will need to succeed
You have an educational background as a pharmacist or a corresponding academic degree. You have regulatory experience and/or experience of Project Management, preferably from an international environment, from the pharmaceutical industry or from regulatory authorities. You have a good knowledge about relevant legislation and guidelines within the field and are familiar with Change Control processes. Experience in the field of Quality Assurance is also relevant.

Who you are
You are independent, driving and interested in working in a dynamic organization. You are well structured and have an analytical and investigational mindset. In addition, we expect you to have a high personal integrity. You will collaborate with many different functions within the company on a global level, which puts high demands on your communication and collaboration skills. You also need to have very good skills in expressing yourself in English.

 

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Your application
We look forward to your application at www.pharmarelations.se as soon as possible before 12th August 2018. Please note that applications by e-mail are not accepted.

For further information please contact Eva Bremberg, Recruitment and Consultant Manager at PharmaRelations Medical & Scientific; 070-165 22 76, eva.bremberg@pharmarelations.se



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PharmaRelations / Fresenius Kabi

PharmaRelations / Fresenius Kabi

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