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Senior Regulatory Affairs Associate -Biologics
Relevant experience in handling the life-cycle management of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies), across various global markets. Good understanding of the regulatory framework, including regional trends, for different types of applications and procedures. Contribute to the preparation (including authoring, where relevant) and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and/or regional perspective. Working knowledge of EU and US regulatory procedures, including post-approval requirements. Knowledge of regulatory legislation in Rest of World (ROW) markets would be an added advantage. Experience in handling CMC-related Health Authority (HA) queries an...