Regulatory Information Manager
Qrios Minds AB / Biomedicinjobb / Göteborg
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hela Sverige About the position
Do you have experience of working with Regulatory Information and would like to work in a global team environment? Are you interested in a new challenge in the ever-changing environment called RIM (Regulatory Information Management)? Then this role is something for you!
We are now looking for a Regulatory Information Manager to join us in Global Regulatory Operations (GRO).
As an industry-leading Oncology Regulatory function, we drive efficiency and innovation to bring medicines to patients as quickly as possible. It's by delivering rapid and global approvals, that we play our part in turning meaningful innovation in drug development strategies into reality. We play a key role in making sure our transformative science born in labs will be transformed into real value for patients.
Collaboration and learning are a big part of how we work and how we win. Within Regulatory we work together across our locations, therapy areas and external community to share learnings and knowledge. It means we are proactive self-starters, comfortable stepping up and taking ownership to enhance our personal and professional development.
We are all compassionate team players and driven achievers, always ready to step up. We are now looking for you who recognise yourself in this and want to join us taking on the Manager Regulatory Information role.
What you'll do
The Regulatory Information Manager is responsible for supporting the management, collection, creation and analysis of regulatory data and regulatory information. The Regulatory Information Manager is an expert in end-to-end Regulatory Information Management (dossier format, publishing, tracking).
Responsibilities
Main responsibilities:
• Represents and manage the interface between Global Regulatory Operations (GRO) delivery units and early as well as late stage drug projects.
• Collaborates with GRO teams and partners to assure efficient delivery of end to end Regulatory Information Management.
• Manage and govern the regulatory data for assigned areas of responsibilities in accordance with regulatory data standards, business processes and regulatory requirements.
• Compiles and delivers XEVMPD, IDMP or other regulatory data submissions to health authorities.
• Develops self in topic areas critical to successful delivery of the RIM remit. Particularly, technical skills and knowledge of international regulations.
• Engages with partners, affiliates, or other customers and stakeholders to manage regulatory data and to ensure compliance with procedures and standards.
• Monitors the environment for changes in legislation related to regulatory information. Reviews and evaluates regulations, guidelines and technical specifications related to regulatory information processes and regulatory information data standards.
• Subject matter expert in the management, analysis and quality control of regulatory data standards and regulatory information.
Your profile
Essential for the role
• University degree in the life sciences or equivalent experience in pharmaceutical/medical industry
• Knowledge of pharmaceutical drug development process
• Strong analytical and critical thinking ability
Desirable for the role
• Good problem and conflict resolution skills.
• Ability to set and manage priorities, performance targets and project initiatives.
• Ability to innovate best practices with business process analysis and design
About the organisation
This position is a consultant assignment at AstraZeneca via QRIOS Life Science & Engineering in Göteborg until 2024-05-24. During this time you will be employed by QRIOS Life Science & Engineering.
QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we are opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.
Ersättning Fast lön
Så ansöker du Sista dag att ansöka är 2023-08-24
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "870".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Qrios Minds AB (org.nr 556599-5999),
http://www.qrios.se/ Arbetsplats Qrios Life Science & Engineering AB
Kontakt Alma Foric
alma.foric@qrios.se 073-850 49 73 Jobbnummer 7987329
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