Regulatory CMC Manager to AstraZeneca
Poolia Life Science & Engineering AB / Kemistjobb / Södertälje
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hela Sverige On behalf of our client, AstraZeneca, we are now looking for a Regulatory CMC Manager for a temporary assignment in Södertälje.
This role offers great opportunities for you to work with global networks, as a member of the CMC Regulatory Compliance organization within the company. CMC Regulatory Compliance is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain. The assignment which is full-time will start as soon as possible with the duration to December 31, 2016, with the possibility of prolongation. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.
Job description
The Regulatory CMC Manager provides CMC regulatory advice on submission strategy and tactics for execution of lifecycle submissions. You will also project manage timely submissions of post approval CMC documentation.
As a Regulatory CMC Manager you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.
As Regulatory CMC Manager you will be expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance within AstraZeneca.
The role expects an understanding of the Operations Function and how it contributes to achieving the objectives of the business as well as an understanding of the functions it interacts with. The role offers opportunities to work with global networks. The role will be based in Södertälje and you will work in a team of 6-8 people.
Qualifications
• Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written Swedish and English
• A minimum of 12 months experience in Regulatory CMC
• A minimum of 24 months experience in Pharmaceutical Production or Quality Assurance or Quality Control or Regulatory Affairs
Benefits
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.
As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
Varaktighet, arbetstid
100 %. Tillträde: Omgående Visstidsanställning till 2016-12-31
Publiceringsdatum2016-03-29ErsättningMånadslön
Så ansöker duSista dag att ansöka är 2016-05-16
Ange följande referens när du ansöker: 661645
Klicka på denna länk för att göra din ansökanKontaktJoakim Karlsson
joakim.karlsson@poolia.seFöretagPoolia Life Science & Engineering AB
AdressPoolia Life Science & Engineering AB
Kungsgatan 57 A, Box 207
10124 Stockholm
KontorsadressKungsgatan 57 A, Box 207
Jobbnummer 2748156
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