Poolia Life Science

Consultant as Regulatory CMC Associate for AstraZeneca

On behalf of our client, AstraZeneca, we are now looking for a Regulatory CMC Associate for a temporary consultant position. CMC Regulatory Compliance & Stability 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 (Gärtuna) and you will work in a team of 8-10 people. The assignment which is full-time will start ASAP with the duration of twelve months. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible. Cover letter and CV must be in English.
Upprättad
Ansökningsfrist
den 1 oktober 2017
Förväntad start.
den 1 november 2017
Antal jobb
1
Anställningsförhållanden
Fast
Antal timmar
Fulltid
Anställning
Fast
Arbetsplats
Sverige > Stockholms län > Stockholms stad

Job description

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

Qualifications

Minimum Requirements – Education and Experience

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

Skills and Capabilities

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

Benefits

We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Skicka din ansökan

Contact Caisy Kader caisy.kader@poolia.se

Please apply by registering your CV on our website. Click on the "Ansök" link below. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail address is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen – the Swedish Association of Staffing Agencies.

ANSÖK

Ansök senast 2017-09-10

 


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