Regulatory CMC Associate to AstraZeneca

Företag Modis Sweden AB


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Regulatory CMC Associate to AstraZeneca

Modis Life Science söker nu en Regulatory CMC Associate till ett konsultuppdrag på AstrraZeneca i Södertälje. Uppdraget är planerat att löpa i 12 mån med chans till förlängning. Uppdragstart januari 2020. Skicka din ansökan senast 26 november. 

About the customer

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. But we´re more than one of the world´s leading pharmaceutical companies. At AstraZeneca, we´re proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain.

We are now looking for a Regulatory CMC Associate. This role is available as a temporary contract and will be based in Södertälje, Sweden.

The role

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 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.
  • The role will be based in Södertälje and you will work in a team of 8-10 people.

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
  • Excellent written and verbal communication skills

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Regulatory CMC Associate to AstraZeneca

Modis Sweden AB