PEMA People is looking for a Regulatory CMC Associate

About 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. 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.

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

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.
The role will be based in Södertälje, Sweden, 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
• 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
• Knowledge of information and document management technology and electronic/paper publishing software
• IT software skills

Are you the right person for the assignment?

Do not hesitate and contact me for further information; Markus Dahl at markus.dahl@pemapeople.se

Please submit your CV and personal letter (in English) today! 

Application deadline: 2018-01-15

Pema People AB är verksamt som bemannings- och rekryteringsföretag sedan 1997. Pema People AB är ett spännande företag i ständig utveckling. För närvarande sysselsätter Pema People ca 1300 personer. Vår framgång bygger på att vi lyckas rekrytera branschens bästa medarbetare och alltid med professionalitet och hjärta i fokus.

Vi matchar de bästa medarbetarna till rätt företag och uppdrag. Att vara extern medarbetare hos oss passar dig som på minsta möjliga tid vill skaffa dig mesta möjliga erfarenhet. Vi ger dig chansen att arbeta på attraktiva arbetsplatser där du utvecklar din kompetens.