Regulatory Project Assistant at AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Mölndal
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hela Sverige Regulatory Project Assistant
We are currently looking for a Regulatory Project Assistant for a 12 months consultant assignment at AstraZeneca.
The Regulatory Project Assistant assists other members of Regulatory Project Management and the Global Regulatory project teams in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. The Regulatory Project Management group sits within the AstraZeneca Global Regulatory Affairs, Patient Safety and Quality Assurance (GRAPSQA) organisation and is accountable for end to end delivery of regulatory submissions in line with business priorities by providing regulatory expertise, efficient project management and strong leadership.
We now have a temporary position as a Regulatory Project Assistant within the CVRM & CTA Regulatory Project Management team in Gothenburg. The assignment is for 12 month starting in January 2019. The Regulatory Project Assistant is a specialist providing regulatory specific administrative support to the Global Regulatory project team to ensure the delivery of business objectives.
Accountabilities/Responsibilities:
• Document management including uploading and tracking regulatory files and systems according to established AstraZeneca procedures and regulatory requirements
• Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
• Be the interface with Health Authority and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of Health Authority portals.
• Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
• Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
• Provide coaching, mentoring and knowledge sharing within the Regulatory Project Management skill group
• Contribute to process improvement
Minimum Requirements
• Relevant qualification and/or experience in science, administration or IT
• Relevant experience from biopharmaceutical industry, or other relevant experience
• Proficient verbal and written English
• Project Management skills
• Experience in document management and tracking databases
Preferred Experience
• Some regulatory/medical/technical experience
• Knowledge of AZ business and processes
• Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools
Skills and Capabilities
• Good written and verbal communication skills
• Cultural awareness
• Proficiency with common document management tools
Business: Dfind Science & Engineering
City: Gothenburg
Last date of application: 2018-10-26. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible.
For more information contact: Malin Wåhlberg
malin.wahlberg@dfind.se or Birgitta Nyström
birgitta.nystrom@dfind.sePlease keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world's second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-10-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-10-26
Ange följande referens när du ansöker: 201179569
Klicka på denna länk för att göra din ansökanKontaktMalin Wåhlberg
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 35
43150 Göteborg
KontorsadressÖstra Hamngatan 35, 41114 Göteborg
Jobbnummer 4409860
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