Lead clinical development oversight for partner-led biosimilar programmes, focusing on PK comparability, immunogenicity, and safety. Collaborate with cross-functional teams to align clinical strategies with EMA, FDA, and UK regulatory expectations.
AdvanzPharma
3 Remote Job Openings at AdvanzPharma
Ensures that Contract Manufacturing Organizations comply with Marketing Authorization and Pharmacopoeial requirements. Manages compliance-related change controls and reviews critical Module 3 documents prior to regulatory submission.
Develop and execute the national medical strategy for the anti-infective portfolio in Italy. Build relationships with Key Opinion Leaders and lead medical education activities, advisory boards, and scientific exchange.
