Regulatory CMC Associate till AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Regulatory CMC Associate
Function / Team / Location:
CMC Regulatory Compliance 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 Operations Regulatory CMC - Analyst 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
- Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
- 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
Job type: Full time
Deadline for applications: 2017-05-08
More information: Julia Gonzales, email@example.com, 0733434654 or Sofie Önnestam, firstname.lastname@example.org, 073 343 99 61
Please send your application in English.
We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.
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