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Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a...
Manage, prepare, finalise CMC sections of EU IMPD/MAA and rest of world equivalent documents. Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior...
Lead design of preclinical and/or clinical studies needed to support health benefit claims. Author, update and maintain relevant scientific documentation. Work closely with Product...
Responsible for providing strategic regulatory guidance on the global pediatric development in alignment with and within the overall development of a product; Lead multiple...