Manager Regulatory Information

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 Manager Regulatory Information to join AstraZeneca, 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
As Manager, Regulatory Information you are responsible for supporting the management, collection, creation and analysis of regulatory data and regulatory information. You represents and manage the interface between Global Regulatory Operations (GRO) delivery units and early as well as late stage drug projects and collaborates with GRO teams and partners to assure efficient delivery of end to end Regulatory Information Management. You will act as the expert in end-to-end Regulatory Information Management including task as dossier format, publishing, tracking etc. In addition you will also:

* Manage and govern the regulatory data for assigned areas of responsibilities in accordance with regulatory data standards, business processes and regulatory requirements.

* 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.

Essential for the role

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Minimum 1-year hands-on experience with regulatory information management
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University degree or equivalent experience in life sciences or technical field
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Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulations and guidance and clearly communicate requirements to immediate stakeholders
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Ability to use project management principles and techniques
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communication skills

Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Please apply as soon as possible but no later than April 7, 2022.



Where can I find out more?

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