CMC Regulatory Affairs associate

Hays are looking for CMC RA Associates for a 1-year contract assignments at AstraZeneca in Södertälje.

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.


Minimum Requirements - Education and Experience


* Degree in Chemistry or Pharmacy or Chemical Engineering, or equivalent experience
* Fluently spoken and written English and Swedish

Desirable for the role


* 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

About Hays
At Hays we invest in lifelong partnerships that empower people and businesses to succeed. With over 50 years' success under our belts and a workforce of 10,000+ people across 32 countries, we've evolved to put our customers at the heart of everything we do.

So much more than a specialist staffing and recruitment business, what really sets us apart is our knowledge through scale, deep understanding and our ability to meaningfully innovate for our customers and candidates. By providing advice, insights and expertise on issues you face today in the fast-paced world of work, we help you make the right decisions to achieve your goals.

You can rely on us to deliver today and help you plan for tomorrow.