Operations Regulatory CMC-Analyst till AstraZeneca

Experis Engineering söker två kemi- eller läkemedelsingenjörer till AstraZeneca för ett konsultuppdrag som Operations Regulatory CMC-Analyst. Uppdraget är 12 månader med önskad start 2017-02-01.

Function / Team / Location:

CMC Regulatory Compliance at AstraZeneca is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain. The role will be based in Södertälje and you will work in a team of 8-10 people.

Candidate Focus & Challenge:

The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory documentation.

You may also coordinate assembly of submission-ready documents to support lifecycle submissions.

You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.

Skills & Experience:

* IT Software skills
* Fluently spoken and written English and Swedish
* Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

Education:
Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering

Other:

* Able to work collaboratively with customers and colleagues to achieve optimum outcomes
* Knowledge of information and document management technology and electronic/paper publishing software
* 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.
* Good communication skills

Application
Apply for this position with a registered or attached resume at www.experis.se. The selection will be ongoing so apply therefore as soon as possible!