CMC Associate Director for AstraZeneca

Presentation

For AstraZeneca we are now looking for a CMC Associate Director for consultant assignments until 2015-06-31 with possibility for extension.

Selections and interviews are held continuously so please apply today!

Arbetsuppgifter

As a CMC Associate Director you will manage projects for new chemical entities or line extensions as a representative of Regulatory CMC. In this role you will contribute to and may lead regulatory CMC components of business related projects. You will provide operational, tactical and increasingly strategic regulatory CMC expertise and direction to AstraZeneca project teams. You will responsible for managing risk using evaluative judgements in complicated or novel situations, ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to development of new guidance.

The assignment is to coordinate and execute all regulatory tasks in the delivery of submissions. This means that you will:

- Provide regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within AZRA and AZ technical functions.
- Define the content of CMC submissions and review and approve regulatory CMC documents on behalf of AZRA for assigned projects
- Represent Regulatory CMC on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated.
- Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical or strategic planning.
- Ensure that the electronic records in internal documentation systems are accurate and complete, e.g. GEL, SLIM and MCM.


Utbildning/erfarenhet

You are an experienced graduate or hold a PhD in a scientific discipline, typically chemistry, pharmacy or a biological science. A significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture is essential. An important requirement is that you have 4-6 years of experience from Regulatory Affairs, with focus on CMC.

Other relevant experience in the pharmaceutical industry for example Pharmaceutical or Analytical Development, Quality Control, Manufacture, might also be considered. You have previously successfully contributed to regulatory submissions. You have also excellent written and verbal communication skills and a strong ability to work collaboratively.

You have a broad understanding of regulatory application procedures and worldwide regulatory CMC requirements for development, license maintenance and renewal submissions. You hold leadership capabilities; understands, identifies and manages risks. Furthermore, you take responsibility for actions and results, and encourage others to do the same. You strive to improve cross-functional work and eliminate activities that do not create value.

Förmåner

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.

Företagsbeskrivning

AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique 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.

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astrazeneca.se


Sluttext

Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. 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 adress is registered.

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

Language

en-GB