Pema People Is Looking For A Regulatory Cmc Manager
Pema People AB / Apotekarjobb / Södertälje
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Nykvarn,
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hela Sverige About AstraZeneca
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 serious 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.
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:
The role of Regulatory CMC Manager is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department.
Main Purpose of the role:
To produce and manage the production of CMC documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable. To ensure that key stakeholders are kept informed of relevant timelines and regulatory commitments for those products. To work as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate
This role will be based in Södertälje, Sweden.
Accountabilities/Responsibilities:
• The Regulatory CMC Manager provides CMC regulatory and compliance advice on regulatory post-approval submissions and project manages 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.
• 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.
• The role offers opportunities to work with global networks.
Minimum Requirements - Education and Experience:
• Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
• Considerable 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
• Project Management skills
• Excellent written and verbal communication skills
• Experience of working within a global environment.
• Team working skills, Flexibility, Adaptability, Influencing, Initiative
• Previous experience of working in a Regulatory CMC environment.
Preferable requirements:
• Experience of working with international markets.
• Experience of working in a LEAN environment.
• IT skills and/or knowledge of information and document management technology and electronic/paper publishing software
Are you the right person for the assignment?
Do not hesitate and contact me for further information; Markus Dahl at
markus.dahl@pemapeople.sePlease submit your CV and personal letter (in English) today!
Pema People AB är verksamt som bemannings- och rekryteringsföretag sedan 1997. Pema People AB är ett spännande företag i ständig utveckling. För närvarande sysselsätter Pema People ca 1300 personer. Vår framgång bygger på att vi lyckas rekrytera branschens bästa medarbetare och alltid med professionalitet och hjärta i fokus.
Vi matchar de bästa medarbetarna till rätt företag och uppdrag. Att vara extern medarbetare hos oss passar dig som på minsta möjliga tid vill skaffa dig mesta möjliga erfarenhet. Vi ger dig chansen att arbeta på attraktiva arbetsplatser där du utvecklar din kompetens.
Varaktighet, arbetstid
Heltid Full-time
Publiceringsdatum2018-01-18ErsättningFixed monthly salary, secure employment and great colleagues!
Så ansöker duSista dag att ansöka är 2018-01-26
Klicka på denna länk för att göra din ansökanKontaktMarkus Dahl
FöretagPema People AB
AdressPema People AB
Ektorpsgatan 6
60337 Norrköping
KontorsadressEktorpsgatan 6
Jobbnummer 3911277
Observera att sista ansökningsdag har passerat.