Associated CMC Director

Are you an experienced Regulatory Affairs CMC Manager with project management background looking for the next step in your career? Do you want to be part of an exciting company who can offer you the challenges that you pursue?

We are looking for an Associate Director CMC to take a contact position based in Macclesfield.

WHAT YOU CAN EXPECT FROM THE ROLE:

- To manage projects for new chemical entities or line extensions as a representative of Regulatory CMC. Will contribute to and may lead regulatory CMC components of business related projects.
- Will provide operational, tactical and increasingly strategic regulatory CMC expertise and direction to AstraZeneca project teams. Will be expected to have effective levels of interactive communication within the project team and directly advising and influencing those within the team.
- Will be expected to manage risk using evaluative judgements in complicated or novel situations.
- Will ensure the application of global CMC regulations and guidance within AstraZeneca. Will contribute to development of new guidance.

WHAT WE WILL BE EXPECTING FROM YOU:

- Experienced graduate or 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.
- Typically six years 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.
- Has successfully contributed to regulatory submissions.

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