Regulatory Project Assistant - Temporary position 12 months
Poolia Göteborg AB / Apotekarjobb / Göteborg
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hela Sverige 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. If you are interested, apply today!
About the consulting assignment
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.
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
About you
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
Warmly welcome to AstraZeneca Gothenburg and Poolia Life Science
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-10-18ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-10-26
Ange följande referens när du ansöker: 51670
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4409445
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