with us. Your Role: Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role): Databases... (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki...
required notifications. Management and responsibility of assigned CMC Regulatory activities and projects. Examples for these comprise... applicable. Accountable and responsible to provide country specific CMC regulatory requirements for dossier strategies and plans...
, variations and maintenance of registered products and medical devices. Maintain regulatory systems and databases and provide... JOB RESPONSIBILITIES: New Product Registration Develop regulatory strategies to achieve high-quality approvals for new products...
, EMEA regulatory requirements. Prepare and review process descriptions and CMC sections of regulatory documents to support... to design and develop cell culture processes for monoclonal antibody and fusion protein production. Provide expert leadership...