CMC Regulatory Affairs Associate

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 join our 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.

The role

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.

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 verbal communication skills
• IT software skills

 

Contact Information
If you have any questions about the position or the recruitment process, please feel free to contact the responsible recruiter:

Ellen Nilsson at Ellen.Nilsson@adecco.se

For inquiries regarding registration, please contact support at info@adecco.se

Welcome with your application! 

Keywords
CMC Regulatory Affairs , Astra Zeneca, Södertälje