CMC Regulatory Expert

2 days ago


Addlestone, United Kingdom Astellas Europe Full time
About Us
Astellas Europe is a leading pharmaceutical company that develops and commercializes innovative medicines for patients worldwide. Our vision is to become a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

About the Job
This permanent, full-time position is based in the United Kingdom and requires fluency in written and spoken business English. The successful candidate will work closely with global health authorities and stakeholders, influencing strategy and facilitating agency meetings. The ideal candidate will have advanced communication and collaboration skills, with the ability to manage complex projects and work cross-functionally.

Essential Skills and Qualifications
  • Extensive experience in CMC regulatory affairs with a proven track record of successful health authority interactions.
  • Strong knowledge of global regulatory aspects for CMC across multiple dosage forms (oral and parenteral).
  • Experience in process development, analytical characterization, and regulatory registration of drug substances/products.
  • Advanced communication and collaboration skills, with the ability to manage complex projects and work cross-functionally.


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