Regulatory Affairs Executive, Europe - News by PLAZOO

Job description
Docpharma is a Belgian based company and a fast growing provider of quality health products. Founded in 1999, the company has been taken over in 2005 by the Indian company Matrix laboratories. The recent take-over of Matrix by Mylan Laboratories Inc., a major US generic company paves the way for future growth. Our pharmaceutical generic division currently has a presence in Belgium, The Netherlands, France, Italy and Switzerland. To give rise at the European expansion, we are looking for several new co-workers to reinforce the International Regulatory Affairs Department. Job offer: Regulatory Affairs Executive, Europe Located at: Offices of the Dutch subsidiary, Apothecon BV in Barneveld or Belgian offices in Heverlee Place in the organisation: The Regulatory Affairs Executive Europe reports to the Director International Regulatory Affairs (IRA) in Heverlee, Belgium and works closely together with all IRA colleagues. Your function: You assume IRA responsibilities for a line of products ensuring quick access to the market You keep abreast of changes in national and European pharmaceutical legislation You provide strategic RA input for new filings on EU level You prepare generic product applications for own developed and in-licensed products You submit and process generic product applications (MRP/DCP) You perform national phase activities in countries where no local RA is present You ensure compliance with RA requirements of the assigned portfolio You efficiently co-operate with your International and national RA colleagues Your profile: You prefarably are a pharmacist You have experience in Regulatory Affairs, preferably with European procedures You are fluent in English and Dutch both written and spoken. Knowledge of any other European language is considered to be an asset. You have the ability to manage multiple tasks and projects of complex nature You can work independently and you are an organised team-player with excellent communication skills You are motivated, flexible and have a pro-active mind-set You are accurate, have a talent for organisation and co-ordination and work well with PC software. Our offer: A function within a young and dynamic company in full expansion Continuous supply of generic pipeline Variety of national and international contacts Future growth potential Competitive remuneration package Interested? Please fax or e-mail your motivation and resume to Karin Van Halewyck at Docpharma Group-International RA Department, Interleuvenlaan 66, B-3001 Heverlee, Belgium, quoting reference IRA/2006/NL/DBS. Fax.:+32 16 38 92 78 - e-mail karin.vanhalewyck@docpharma.be

Working location :	Heverlee, België
Type of job :	Full time
Contract type :	Not relevant
Education level :	University (Bachelor)
Experience in years :	None
Job starts :	Immediately
Solicitation ends on :	Saturday, 3 February 2007
Contact person
Contact name :	Mevr. K. Van Halewyck
Phone number :	003216389277
Email address :	karin.vanhalewyck@docpharma.be

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