Regulatory Project Assistant

Kort om tjänsten

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. Consultant employment by Dreamwork.
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.

About the job

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

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

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Skills and Capabilities
• Good written and verbal communication skills
• Cultural awareness
• Proficiency with common document management tools

Welcome with your application by register your resumé in english as soon as possible. The selection process is ongoing.