CMC Regulatory Affairs Associate to 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 entier mälardalen, you will be able gain a broad  work experience through many companies in varied roles and assignements.

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. Your granted a competitive sallary, 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 generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status. You may also support externalisation 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.




Working hours
We offer a full time job as employee type tillsvidareanställd that initiates with a 6 month provanställning period. The assignment varies in length depending on the company and role. 

Qualifications
Minimum Requirements
• Degree in Chemistry or Pharmacy or Chemical Engineering, minimum 120 p or equivalent experience
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

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 January 13th. Continueus assortment and  interviews  will be on-going 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 in är specialiserade inom kompetensområdet naturvetenskap och är en del av Randstad, som med verksamhet i 38 länder är världsledande inom rekrytering och konsultuthyrning. Genom detta globala nätverk och i kombination med en stark lokal förankring kan vi erbjuda ett stort utbud av varierande och utvecklande uppdrag och tjänster för dig som är specialist inom inom life science.


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.