Regulatory CMC Associate

Are you an organised person with excellent written as well as communication skills and experience in Post Approval Regulatory CMC including CMC documentation? Would you like to apply your expertise in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca's global supply chain. We are now looking for Regulatory CMC Associates to join our product teams located in Södertälje, both in permanent and temporary positions.

We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other teams in AstraZeneca.

At AstraZeneca Campus Södertälje, we come together in an innovative and high-tech environment to manufacture life-changing medicines. Welcome to our world, where we have 42 different nationalities, half of our leaders are women, and we all work actively for a healthier world for our employees and our patients.

The role
As a Regulatory CMC Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.

You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.

You may also support externalisation projects and transfer of CMC documentation to external partners.

Essentials in the role

* Degree in Chemistry or Pharmacy or Chemical Engineering
* Fluently spoken and written English and Swedish
* Experience in Post Approval Regulatory CMC including CMC documentation authoring
* Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

To succeed in the role you have excellent written and verbal communication skills. You work collaboratively with customers and colleagues to achieve optimum outcomes. You have experience from using Document Management systems. You manage working with short and / or changing timelines. You are highly organized and have attention to details. You plan and control your own workload effectively and manage expectation of others.

Why AstraZeneca? Our offer to you
When we at AstraZeneca see the chance to change, we take this opportunity - for every opportunity, no matter how small, can be the beginning of something big. Delivering medicine that changes people's lives is about having an entrepreneurial spirit - finding moments and understanding its potential.

We are therefore looking for you, who together with your team will make a difference for patients' lives every day. We at AstraZeneca welcome your positive attitude and your desire to develop both yourself and the department. You will get use for your drive and your ability to work carefully and structured even at a high tempo.

Welcome to learn more about us by visiting our AZ YouTube channel and watch our film series: "A life-changing day" https://bit.ly/2TioMxP and visit our website: https://careers.astrazeneca.com/life-at-astrazeneca

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

Please submit your application in English no later than November 29, 2020.

For further information regarding this role please contact Malin Kvist, tel 08-552 514 98 or Helena Rotkvist, tel 072-204 21 88.