CMC Regulatory Affairs Associate

Global Regulatory Excellence

Hays Specialist Recruitment is now looking for 2 CMC Regulatory Affairs Associates to join the Global Regulatory Excellence Team for 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 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.

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 up to approval of CMC documentation supplied by our CMC Regulatory teams.
You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.

You may also support externalisation projects and transfer of CMC documentation to external partners.

Minimum Requirements - Education and Experience

* Degree in Chemistry or Pharmacy or Chemical Engineering
* Fluently spoken and written English and Swedish
* Experience in Post Approval Regulatory CMC including CMC documentation authoring
* Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

Skills and Capabilities

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

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.