Consultant Assignment as Regulatory Affairs Manager at AstraZene
Proffice Life Science AB / Apotekarjobb / Södertälje
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We are now looking for candidates or subcontractors for a 6 month part time (50% or more) consultant assignment within Regulatory Affairs at AstraZeneca Nordic Baltic Marketing Company. As one of the members of the Nordic Baltic Regulatory Affairs Team, you will play an important role by continuously working for highest availability and best regulatory standards in order to ensure patient's safety of AstraZenecas products in the Nordic markets. The assignment will start in August.
Your Arena
As Regulatory Affairs Manager you will work with products in development phase as well as in life cycle management. You will be responsible for all regulatory submissions for a product portfolio for the Nordic markets and developing contacts with the Health Authorities across the Nordic region. The position offers many contacts internally within the Nordic Marketing Company as well as within the global functions in AstraZeneca and with Health Authorities. The position is located in Södertälje, Gärtuna.
Main duties:
You will be
• responsible for regulatory submissions for a product portfolio supporting rapid and high quality approvals for marketing
• accountable for the regulatory compliance of our products with authorities and that the product information and labelling (SmPC, PIL, and artwork) are up-to-date. This work also includes translation into local languages.
• communicating with authorities on planned and pending items
• cooperating with functions within the marketing company as well as working cross functionally with the global teams in R&D, Operations etc.
Business: Dfind Science and Engineering
City: Södertälje
Job type: Part time, 50%
Deadline for applications: 2014-06-30 Note: Candidate selection and presentation will be done continuously.
Qualifications:
• Masters degree in Pharmacy, Science or other related discipline.
• Minimum 3-5 years experience within Regulatory Affairs and specifically experience within Nordic Regulatory Affairs.
• Excellent verbal and written communication skills i.e. speak and write in English and at least one of the Nordic languages fluently.
• A high degree of computer application literacy.
• Demonstrated good organisation and planning skills in order to ensure prioritization of tasks.
• Experience working with continuous improvements and lean philosophy is beneficial.
• Demonstrated good organisation and planning skills in order to ensure prioritization of tasks.
Success factors
In order to be successful in this role, you shall be structured and precise and have the ability to see the bigger picture and to identify business opportunities. You are able to act decisively, since many situations require effective decisions. As a team member, collaboration is a key factor - we are here to work together. Since the position requires frequent contacts internally as well as externally we see you being positive and able to establish fruitful relationships.
Please send your application in English.
We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.
More information: Maria Lönn: 073 343 43 35,
maria.lonn@dfind.seOrganization/Business description:
Dfind Science & Engineering is a staffing and recruitment company with competences within science and engineering as our specialisation. Our commitment and service help people and companies to find solutions to develop.
Publiceringsdatum2014-06-19Arbetstider och omfattningDeltid Visstid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2014-09-17
Ange följande referens när du ansöker: 200602266
Klicka på denna länk för att göra din ansökanKontaktMaria Lönn 0733434335
maria.lonn@dfind.seFöretagProffice Life Science AB
AdressProffice Life Science AB
Lunagallerian 1
15172 SÖDERTÄLJE
KontorsadressLunagallerian 1, 15172 SÖDERTÄLJE
Jobbnummer 1916551
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