Bachelor's degree or equivalent in a relevant scientific discipline; Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences or related disciplines preferred.
8+ years of directly relevant Regulatory Affairs experience , with a strong CMC background.
Strong experience with EU/EEA clinical trial regulatory requirements and CMC regulatory documentation.
Practical experience performing regulatory change assessments , including assessing the impact of CMC, manufacturing, supply or labelling changes.
Experience determining whether changes require substantial or non-substantial modification under applicable EU clinical trial requirements.
Experience supporting EU Clinical Trials Regulation submissions .
Strong CMC authoring and review expertise, including experience with simplified IMPDs or comparable CMC documentation .
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