Regulatory Affairs Manager

TFS Trial Form Support / Apotekarjobb / Lund
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TFS, with headquarters in Lund, Sweden, is the largest non-listed European clinical Contract Research Organisation (CRO). Clinical services are provided by four business areas; TFS ExploreT, TFS DevelopT, TFS PeopleT and TFS AcademyT , with annual net revenue greater than ? 35 million, global operations in 17 countries and 500 employees worldwide. Detailed information about TFS business areas, global locations and recent press releases can be obtained at www.trialformsupport.com

Do you want to make a difference as our new Regulatory Affairs Manager?

We have grown our client base and are now looking for a well-experienced Regulatory Affairs Manager. You will be part of a dynamic and growth-oriented organisation with global presence and great development opportunities for the right candidate. In this role you will have the opportunity to influence the development at TFS. You appreciate a flexible working environment filled with interesting and stimulating assignments. Our Regulatory Affairs department is involved in various, exiting projects from early development phase to market approval.

As Regulatory Affairs Manager you will work together with our international customers. You report directly to our Director Global Medical Affairs based in Lund, Sweden.

Further you are responsible for:

• Preparation, review and compilation of regulatory submissions and variations
• Preparation, review and compilation of clinical trial applications/ clinical investigation plans
• Liaison with international authorities in Europe and notified bodies
• Advise to regulatory issues and answer questions
• Maintain a high level of competence regarding international regulatory requirements and regulatory procedures

We expect you to fulfil the following requirements:

• Suitable academic education in life science such as pharmaceutical science, medicine, biomedicine, biology or similar
• At least 5 years of international experience from working with regulatory affairs within the pharmaceutical industry or regulatory authorities. Experience from Medical Device and/ or In vitro Diagnostic is an advantage.
• Very good communication skills in spoken and written English. Danish and Swedish are an advantage.

The position requires the following personal profile:

• High level of engagement and driving personality
• Accurate way of working
• Responsive
• Ability to adapt quickly to different tasks and situations

We welcome you to join us and to contribute to the TFS success story!

In this recruitment we cooperate with Proffice Life Science. For more information about this position please contact recruitment consultant Claudia Lindwall +46 733-43 48 50 or Camilla Wern +46 733-43 44 62.

The selection and interview process is ongoing, so apply as soon as possible, but not later than April, 15. Send in your application in English via www.proffice.se.

Ort: Lund

Uppdragsgivare: TFS Trial Form Support

Publiceringsdatum
2012-03-09

Så ansöker du
Sista dag att ansöka är 2012-04-15
Ange följande referens när du ansöker: 200284253
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Kontakt
Claudia Lindwall

Företag
TFS Trial Form Support

Adress
TFS Trial Form Support

Jobbnummer
1182425

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