Regulatory Affairs CMC Manager
AstraZeneca R & D Lund / Apotekarjobb / Lund
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Description
This position is planned to be filled in Lund or Södertälje in Sweden.
You will manage small projects or segments of large projects for new chemical entities or line extensions as a representative of Regulatory CMC. You will provide regulatory CMC knowledge and direction to AstraZeneca project teams. Your advice and services to the teams will assist team members in timely decision-making. You will ensure that global CMC regulations and guidances are followed within AstraZeneca.
Responsibilities
Your main responsibility will be to ensure that project activities are delivered to a high standard, agreed time scales and meet AstraZeneca business requirements, compliance requirements and regulatory authority expectations worldwide. You will do that by define the CMC content of clinical trial applications or marketing authorisation applications, and review and approve the documents on behalf of Regulatory Affairs. The applications may be global in scope.
In your role you will establish networks with relevant technical functions such as Process R&D, Pharmaceutical & Analytical R&D or Operations, and with marketing companies around the world. You will provide the technical functions with recommendations and decisions on regulatory issues relating to CMC, including risk identification and mitigation. You will provide clear and concise guidance on current CMC regulatory requirements to support planning a couple of years into the future.
Requirements for education and experience
You have a university degree in a scientific discipline, typically chemistry, pharmacy or a biological science. You have a general knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture, and you have typically four years experience from the pharmaceutical industry. You have some understanding of principles and concepts in regulatory affairs. You have good knowledge in written and spoken English.
You will use your own previous knowledge, in combination with a coach/mentor programme for regulatory CMC knowledge, to deliver to high standards and to influence others, with an increasing freedom to act without direct supervision.
Publiceringsdatum2008-03-11Anställningstyp/arbetstiderTills vidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2008-03-19
More information
For more information please contact Per Niklasson, +46 46 33 72 03
Please apply by submitting your CV and personal letter marked "Regulatory Affairs CMC Manager" via
www.astrazeneca.se no later than March 19, 2008 .
Ange följande referens när du ansöker: SWE0000005H
FöretagAstraZeneca R & D Lund
AdressAstraZeneca R & D Lund
Scheelevägen 2
22187 LUND
KontorsadressAstraZeneca R & D Lund
Scheelevägen 2
LUND
KontaktuppgifterTelefonnummer: 046-336000
Faxnummer: 046-337193
Jobbnummer 158986
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