Regulatory Affairs Officer
ALK Sverige AB / Administratörsjobb / Göteborg
Observera att sista ansökningsdag har passerat.
Visa alla administratörsjobb i Göteborg,
Mölndal,
Partille,
Kungälv,
Lerum eller i
hela Sverige Visa alla jobb hos ALK Sverige AB i Göteborg,
Kungsbacka eller i
hela Sverige ALK is a global pharmaceutical company focusing on allergy treatment, prevention and diagnosis. Our mission is to improve quality of life for allergic people by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.
ALK has close to 1,500 employees with subsidiaries, production facilities and distributors worldwide. The company is headquartered in Hørsholm, Denmark and listed on the OMX Nordic Exchange Copenhagen.
ALK Nordic is recruiting a Regulatory Affairs Officer
Regulatory Affairs in ALK Nordic is responsible for pharmaceutical registration processes, adverse event reporting, medical information services and quality assurance in the Nordic countries. The department has a close cooperation with our headquarter in Denmark.
As a Regulatory Officer you will have a close co-operation with and report to the Regulatory Manager.
Areas of responsibility:
You will be responsible for variations, renewals and other areas of contact to the Nordic medicinal agencies concerning our marketing authorizations for our marketed products and for products being prepared for launch. This includes as well the implementation of SmPC’s, package information leaflets, labelling and package materials.
You will furthermore be responsible for case management and reporting of product complaints and adverse events.
To assist in ensuring organisational compliance within ALK Nordic, you will also be responsible for the development and updates of local SOP’s within the area of responsibility of the Regulatory department as well as participate in audits/inspections.
Lastly, you will be in charge of managing our database of product related Q&A’s and you are expected to handle certain customer inquiries.
Your profile:
We expect that you are a certified pharmacist by training or have similar level of scientific educational background as well as accumulated experience in the outlined areas of responsibility.
You work structured and analytical with thoroughness. You can manage several tasks simultaneously without losing focus. Your colleagues acknowledge and appreciate your ability to take responsibility and own initiatives as well as achieve a constructive cooperation with colleagues and stakeholders.
You are fluent in English and in at least one Nordic language (preferably Swedish). Familiarity with the Finnish language is an advantage.
The job assumes good skills in working with Microsoft Office.
Your workplace is at our Nordic office in Kungsbacka, Sweden.
Please submit your application including your resume/CV latest February 22, 2010 by e-mail to our Human Resources:
tove.eneroth@alk-abello.comIf you are interested in knowing more about the position, please don’t hesitate to contact Ann-Mari Eriksson, Regulatory Affairs Manager. Office phone: 0300-185 45 alt. +46 300 185 45.
Publiceringsdatum2010-02-05Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2010-02-22
Ansökan kan skickas till e-postadress:
tove.eneroth@alk-abello.comFöretagALK Sverige AB
AdressALK Sverige AB
Box 10073
43421 KUNGSBACKA
KontorsadressSmörhålevägen 3
KontaktuppgifterTelefonnummer: 0300-185 45
E-postadress:
tove.eneroth@alk.se Jobbnummer 581493
Observera att sista ansökningsdag har passerat.