Regulatory Affairs Manager at AstraZeneca
Dfind Engineering / Apotekarjobb / Göteborg
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We are now looking for 2 Regulatory Affairs Managers for assignments at AstraZeneca.
Uppdragsgivare: Dfind Science & Engineering
Ort: Göteborg
Omfattning: Heltid
The Arena
The Regulatory Affairs Manager is responsible for project management and coordination of the content of all regulatory submissions sent to health authorities and ensures that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc.
Description
The assignment is to coordinate and execute all regulatory tasks in the delivery of submissions. This means that you will:
• Prepare and deliver regulatory operational plans for allocated projects/products.
• Contribute to solutions to regulatory issues.
• Project manage quality regulatory submissions to agreed project targets.
• Provide operational regulatory input and guidance in cross-functional teams.
• Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives.
Accountabilities and Responsibilities
• Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
• Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
• Acting as a project coordinator for nominated products/projects, work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions which will achieve the following across a range of markets
• Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program
• Support RAD or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies
Education and Experience
• University Degree in Science or related discipline
• Two years experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or experience at a health authority
• Excellent written and verbal communication skills
• Thorough knowledge of the drug development process
• Scientific knowledge sufficient to understand all aspects of regulatory issues.
• Strong ability to work collaboratively.
• An important requirement is that the successful candidate has experience from Regulatory Affairs from medical device or the pharmaceutical business.
Sista dag att ansöka är 2014-09-24
För information: Eleonor Ehrman 0733-434109 or Per Hillertz 0733-434018
Organisations-/företagsbeskrivning:
Dfind Science & Engineering är ett konsult- och rekryteringsföretag specialiserade på kompetenser inom naturvetenskap och teknik. Med engagemang och lyhördhet hjälper vi människor och företag att hitta lösningar för att utvecklas. Hos oss har du möjlighet att utveckla dina kunskaper och färdigheter genom uppdrag hos våra utvecklings- forsknings- och produktionsintensiva kunder i Norden.
Vi tycker att det är viktigt att all kompetens på arbetsmarknaden tillvaratas. Vi välkomnar alla sökande och eftersträvar mångfald. Dfind Science & Engineering ett auktoriserat bemanningsföretag via Almega och följer deras kollektivavtal.
Publiceringsdatum2014-09-20Arbetstider och omfattningHeltid Visstid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2014-09-24
Ange följande referens när du ansöker: 200641964
Klicka på denna länk för att göra din ansökanKontaktEleonor Ehrman
eleonor.ehrman@dfind.seFöretagDfind Engineering
AdressDfind Engineering
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 2003979
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