Regulatory Affairs Manager - Based in Athens Do you want to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? Do you want to develop and implement external and internal collaborations to address patient needs through innovative partnerships that advance patients goals and unmet needs? Then AstraZeneca might be the place for you! It's a place for continuous learning, exchanging knowledge and building best practices to grow your career.
ABOUT ASTRAZENECA AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Here you will have the opportunity to make your mark as you do something rewarding for patients, healthcare and our wider society. Jump in and be a part of it.
SITE DESCRIPTION Welcome to Athens, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves.
BUSINESS AREA The Biopharmaceuticals Regulatory Affairs Management group 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.
The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading / contributing to the end-to-end planning, coordination, and execution of assigned deliverables. The RAM manages delivery of submissions to time, quality, and in compliance with applicable regulations. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to Regulatory and cross-functional teams working globally and locally to ensure the delivery of business objectives.
What you'll do Ensure that regulatory deliverables for assigned products are completed within set timelines and to high quality standards Manage the timely preparation and submission of local regulatory submissions at launch and throughout the life cycle and local artwork of the assigned products Validate AstraZeneca promotional and non-promotional materials and activities for assigned products according to National Regulatory Authority and local legislation Participate in cross-functional teams providing regulatory advice, supporting new product launches, discontinuations and stock management Ensure compliance with requirements from National and European regulatory agencies Represent the organization externally to the National Regulatory Authority and other government bodies Essential for the role Bachelor's degree (life sciences educational background will be considered an asset) 3-5 years of Regulatory experience within the biopharmaceutical industry Knowledge of the drug regulatory approval processes in the European Union Understanding the local and European regulatory legislation Knowledge of European Union Good Regulatory Practices framework Excellent knowledge of SFEEs Code of Ethics Project management skills Fluency in Greek and English language (both written and verbal) 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.
So, what's next? Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours. Where can I find out more? Follow AstraZeneca on LinkedIn here Follow AstraZeneca on Facebook here Follow AstraZeneca on Instagram here
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