CMC Associate Director, Astra Zeneca

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. We expect the successful candidate to have effective levels of interactive communication within the project team and directly advising and influencing those within the team.

You are responsible for managing risk using evaluative judgments in complicated or novel situations, ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to development of new guidance.

You will be a member of a PAR&D or PR&D project team.

Job Description:

Provide regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within AZRA and AZ technical functions. Ensure project activities are delivered to a high standard, agreed time scales and meet AZ business requirements, compliance requirements and regulatory authority expectations worldwide.

Define the content of CMC submissions and review and approve regulatory CMC documents on behalf of AZRA for assigned projects. Such submissions are clinical trial applications (IND, CTA, etc.), marketing authorization applications (NDA, MAA, JNDA etc.) or line extensions. The applications may be global in scope.

Lead CMC submission management team. Ensure the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.


Background and experience:

We believe you have a PhD in a scientific discipline such as chemistry, pharmacy or a biological science. A significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture.

Six years of experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture, might also be considered.

You are fluent in English, both written and spoken.

You are a leader that understands, identifies and manages risks. Professional communication skills are required in order to negotiate and influence others, as well as cultural sensitivity.


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För mer information om Experis konsultverksamhet och vad vi kan erbjuda dig är du välkommen att kontakta Gabriella Mjölnevik på telefon, 031-61 72 39 eller mail: gabriella.mjolnevik@se.experis.com.

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