Regulatory CMC Associate till AstraZeneca

Poolia Life Science & Engineering AB / Kemistjobb / Stockholm
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On behalf of our client, AstraZeneca, we are now looking for a Regulatory CMC Associate for a consultant position. CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain. The role will be based in Södertälje (Gärtuna) and you will work in a team of 8-10 people. The assignment which is full-time will start ASAP with an initial duration throughout 2019. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.


Om tjänsten
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.

The role will be based in Södertälje, Sweden, and you will work in a team of 8-10 people.

Vem är du?
Education And Experience

Degree in Chemistry, Pharmacy or Chemical Engineering
Fluently spoken and written English and Swedish
Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable

Skills And Capabilities

Able to work collaboratively with customers and colleagues to achieve optimum outcomes
Ability to work with short and/or changing timelines
Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
Good communication skills
Knowledge of information and document management technology and electronic/paper publishing software
IT software skills

Om verksamheten
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most severe diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Operations Regulatory is a global function within Global Quality Supply Chain, that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the world-wide AstraZeneca supply chain.


OM POOLIA - VAD VI KAN ERBJUDA DIG

Vi på Poolia Life Science är specialister som rekryterar specialister inom life science. Självklart omfattas din anställning på Poolia av kollektivavtal, försäkringar och tjänstepension. Vi vill att Du ska må bra och trivas med oss på Poolia och därför erbjuder vi Dig friskvårdsbidrag, företagshälsovård och ordnar regelbundet sociala aktiviteter. Hos oss får du en engagerad konsultchef som finns tillgänglig och håller löpande kontakt med Dig och kundföretagen under hela din anställning. Vårt mål är att vi ska trivas och utvecklas tillsammans.

Varaktighet, arbetstid
Heltid Tillsvidare

Publiceringsdatum
2019-03-16

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2019-03-21
Ange följande referens när du ansöker: 53049
Klicka på denna länk för att göra din ansökan

Kontakt
Hanna Peterson hanna.peterson@poolia.se 0703662960

Företag
Poolia Life Science & Engineering AB

Adress
Poolia Life Science & Engineering AB
Box 207
10124 Stockholm

Kontorsadress
Box 207

Jobbnummer
4672670

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