Job Description

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\xe2\x80\x99re our kind of person.

Key Result Areas/ outputs

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 \xe2\x80\x93

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\xe2\x80\x99s why we work, on average, a minimum of three days per week from the office. But that doesn\xe2\x80\x99t mean we\xe2\x80\x99re 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\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s 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\xe2\x80\x99re on an exciting journey to pioneer the future of healthcare.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

Date Posted 09-Feb-2024

Closing Date 28-Feb-2024

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca