Regulatory Project Assistant - AstraZeneca Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma in Gothenburg is searching for a Regulatory Project Assistant for an exciting 12 month consultancy assignment at AstraZeneca in Mölndal.
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
About ALTEN:
FOR OVER 20 YEARS, ALTEN HAS DEVELOPED ITS BUSINESS BY KEEPING TO THE CORE VALUES ??THAT HAVE BUILT UP THE COMPANY'S SUCCESS. EVERY YEAR, HUNDREDS OF ALTEN CONSULTANTS HAVE BEEN GIVEN THE OPPORTUNITY TO EMBARK ON CHALLENGING TECHNICAL PROJECTS FOR OUR CUSTOMERS. ALTEN HAS A TRADITION OF DEVELOPING PRODUCTS IN MANY AREAS, AND HISTORY IN SWEDEN IS BASED PRIMARILY ON SKILLS IN MECHANICS, SOFTWARE AND ELECTRONICS. THANKS TO A SUCCESSFUL CONCEPT IN WHICH WE UTILIZE THE EXPERTISE OF EXPERIENCED CONSULTANTS AND DEVELOP YOUNG ABILITIES TOWARDS A SUCCESSFUL CAREER, WE HAVE GAINED GROUND IN MANY INDUSTRIES. OUR PHARMA INITIATIVE IS BASED ON THE SAME SUCCESSFUL CONCEPT WITH THE SAME STRONG STRUCTURE, BUT IN A NEW EXCITING INDUSTRY AND A NEW FIELD OF EXPERTISE THAT INCLUDES KNOWLEDGE IN CHEMISTRY, BIOTECHNOLOGY AND BIOMEDICINE.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-10-18ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-26
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4409468
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