CMC Regulatory Affairs associate till AstraZeneca, Södertälje

Job description
Working as a consultant at Randstad Life Science is an exciting opportunity to grow within the life science industry. Due to our wide customer portfolio that spans across the entire mälardalen area, you will be able to gain a broad  work experience through many companies in varied roles and assignments.

Our ambition is to become your  indefinite career partner

Your daily work is carried out at the company for your current assignment, while Randstad Life Sciences is your employer. You're granted a competitive salary, benefits, collective agreement. We're responsive and listen to your desired  assigments and roles.

We invest in our consultants

At Randstad Life Sciences we're excited to announce that we have a unique offer to you which can be utilized after working with us for a total of one year that enables you to take extra vacation days and/or attend training courses.

Our mission, with your career in focus, is to help you achieve your full potential!  

Responsibilities
CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca’s global supply chain. We are looking for CMC Regulatory Affairs Associates to our product teams for post approval regulatory management located in Södertälje.

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 AZ teams.

As a CMC Regulatory Affairs Associate, your main focus will be to compose CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status. You may also support internal and  external projects where transfer of CMC documentation to external partners is an important and regular task. 

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

Qualifications
Minimum Requirements
A degree in natural Science or corresponding work experience within the life science industry. 
Fluently spoken & written English and Swedish.
Work experience from the life science industry within quality, such as QC-lab, QA, Process engineer or regulatory affiars.


Skills and Capabilities
 Experience from and interest of using Document Management systems
Knowledge of information and document management technology 
Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
Ability to work with short and / or changing timelines
Able to work collaboratively with customers and colleagues to achieve optimum outcomes
Excellent written and verbal communication skills
IT software skills 


Application
Application is due by 28th of May . Continueus selection and  interviews  will be ongoing during the application period. Please note that due to GDPR we can not accept resume or applications via mail.

We strive for diversity and welcome all applicants.  

About the company
Randstad Life Sciences are specialists within the field  science and is part of Randstad. We operate  in 38 countries and are a world leading  HR services provider.  Through our global network in combination with a strong local pressence and varied assginments that challenge you, we can offer you a wide range of opportunities that unfold your competence and experience, thus making you an sought out life science specialist.

It’s the human side of our business that makes the difference. That’s why we combine the power of today’s technology with the passion of our HR professionals to create an experience that’s inherently more human.

We call this Human Forward.