Regulatory Consultant (Quality), Therapeutic Products Branch

BIOPOLIS (HELIOS BUILDING)onsitemid

Posted today · via Workday

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About this role

[What the role is] Quality Evaluation of Therapeutic Products [What you will be working on] Conduct scientific evaluation and lead evaluation strategies for biosimilar and biological products. Provide regulatory advice to industry on development and data requirements for biosimilar and biological products. Develop and implement regulatory frameworks for biosimilar assessment and biological product evaluation, which includes leading cross-functional technical discussions and providing strategic advice on complex submissions. Develop scientific opinions, position papers, and regulatory guidelines for biosimilars and biologics. Mentor and build technical capability within evaluation teams and lead strategic initiatives.…

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This role is based in BIOPOLIS (HELIOS BUILDING). We weight your proximity and willingness to relocate.

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