Regulatory Affairs Managers for future assignments at AstraZenec
Dfind Engineering / Apotekarjobb / Göteborg
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For future assignments at AstraZeneca we are now looking for Regulatory Affairs Managers. The Regulatory Affairs Manager is responsible for project management and coordination of the content of regulatory submissions sent to health authorities. The individual will ensure that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc.
Uppdragsgivare: Dfind Science & Engineering
Ort: Göteborg
Responsibilities:
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
• Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program
Minimum Requirements - 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.
• Experience from Regulatory Affairs from medical device or the pharmaceutical business.
Personal Qualities:
We put high importance in personal qualities. Candidates should possess good social skills and be strong team players. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem solving attitude. It is essential to have good organizational and communication skills.
Deadline for applications: 2014-09-28
Information: Per Hillertz,
per.hillertz@dfind.se [ mailto:
per.hillertz@dfind.se ] or Eleonor Ehrman,
eleonor.ehrman@dfind.se [ mailto:
eleonor.ehrman@dfind.se ]
Organization/Business description:
Dfind Science & Engineering is a staffing and recruitment company with competences within science and engineering as our specialization. Our commitment and service help people and companies to find solutions to develop.
Publiceringsdatum2014-09-23Arbetstider och omfattningHeltid Visstid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2014-09-28
Ange följande referens när du ansöker: 200637222
Klicka på denna länk för att göra din ansökanKontaktPer Hillertz
per.hillertz@dfind.seFöretagDfind Engineering
AdressDfind Engineering
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 2007252
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