CMC Regulatory Affairs Associate - AstraZeneca

CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca’s global supply chain. QRIOS Life Science are looking for consultant within CMC Regulatory Affairs to join AstraZenecas CMC team focused on divestment related activities 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.

About the position
As a CMC Regulatory Affairs Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status. You will 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 as well as external partners to obtain information that supports the generation of regulatory CMC documentation.

The role also includes maintenance and change control management of external partners CMC documentation in AstraZeneca systems.

Your profile
Minimum Requirements - Education and Experience

• Degree in Chemistry or Pharmacy or Chemical Engineering, 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
• 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
• High level understanding of GMP and working in a regulated environment
• High level understanding of CMC Regulatory
• Excellent written and

About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.