ABOUT ASTRAZENECA
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Preparation and submission of Post Approval Changes
Ensure compliance of labelling (and mock-ups) with the Company Core Data Sheet
Review of Labels
Maintenance of all Regulatory trackers and archival
Site registration and Import licence
Managing Registration sample right from dispatch of samples till the report
Licence Life cycle management
Response to HA Queries
Preparation and Filing of Test License (TL) application/Additional TL/Renewal of TL application
Adherence to AZ and industry codes of conduct, ethics and good regulatory practices
Align with the values and vision of AZ
Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement
Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information)
Disclose potential breaches of codes or conducts
Office Working Requirements –
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en