Regulatory CMC Associate
AstraZeneca Södertälje / Kemistjobb / Södertälje
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hela Sverige As an innovation-driven biopharmaceutical business, AstraZeneca is making a genuine difference to healthcare around the globe with patients need at the heart of everything we do. A truly global company, we are active in over 100 countries and have a growing presence in emerging markets such as China, Brazil, India and Russia. For all our people, we offer challenging and rewarding opportunities across a wide range of specialist disciplines.
The arena
The role of Regulatory CMC Associate is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) delivery within our CMC Regulatory Compliance Department. CMC Regulatory Compliance is part of the Global Operations Quality function.
The role
Accountabilities/Responsibilities:
The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory documentation.
You may also coordinate assembly of submission-ready documents to support lifecycle submissions.
You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.
This role is available as permanent contract and will be based in Södertälje, Sweden.
Minimum Requirements - Education and Experience
Essential requirements:
Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
Experience in the Pharmaceutical industry, for example Pharmaceutical Production or Regulatory Affairs or Quality Assurance and R&D.
Fluently spoken and written English and Swedish
Team working skills, Flexibility, Adaptability, Initiative
Preferable requirements:
Previous experience of working in a regulatory CMC environment.
Experience of working within a global environment.
Experience of working in a LEAN environment.
Excellent written and verbal communication skills
IT skills
For more information
For further information regarding this role please contact Mauro de Sario at +46 8 553 21207 or Karin Grosch at +46 8 552 540 98.
Please submit your application in English no later than January 31st.
Applications will be reviewed continuously. Interviews are planned for w/c February 8th.
TO APPLY, please visit
www.astrazeneca.comVaraktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-01-15ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-01-31
Ange följande referens när du ansöker: SOD000002C5
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Västra Mälarhamnen 9
15185 Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 2618310
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