Astra Zeneca is looking for a Regulatory Afffairs Manager
Jurek Rekrytering & Bemanning AB / Ekonomichefsjobb / Göteborg
2014-05-05
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hela Sverige Publiceringsdatum2014-05-05Dina arbetsuppgifterThe 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.
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.
• 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
Vem är du?
• 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.
Du erbjuds
You will find yourself in an innovative and creative workplace. For this assignment you have to be available immediately and until 2014-05-31. You will be working as a consultant for Jurek Rekrytering & Bemanning at AstraZenecas office in Mölndal during May. For additional information contact Susanna Filipsson at
susanna.filipsson@jurekbemanning.se . I am looking forward to see your application, please visit us at
www.jurekbemanning.se .
Om företagetAstraZeneca 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. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Arbetstider och omfattningHeltid Visstidsanställning
ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2014-05-07
Vi föredrar ansökningar via webben
Ange följande referens när du ansöker: 2033
Klicka på denna länk för att göra din ansökanKontaktSusanna Filipsson
FöretagJurek Rekrytering & Bemanning AB
AdressJurek Rekrytering & Bemanning AB
Biblioteksgatan 11
11146 Stockholm
KontorsadressBiblioteksgatan 11, Stockholm
Jobbnummer 1862028
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