Gigg från: Alten Sverige AB
Biologics Operations Submission Associate Manager
The Biologics Operations Submission Manager (Bio Ops SM) will work within Global Technical Operations (GTO) and, work with BPD and Biologics Operations scientists, managing the preparation and review process of regulatory documents for the quality (CMC) modules. As a member of the SM team, they will coordinate and consult on regulatory filings and writing processes; identify and promote initiatives to advance the Astra Zeneca biologics pipeline and support marketed products. MAIN RESPONSIBILITIES: • RESPONSIBLE FOR BLA/MAA DELIVERY AND LIFE CYCLE MANAGEMENT OF REGULATORY SUBMISSION DOCUMENTS WORKING WITHIN GLOBAL TECHNICAL OPERATIONS • LEAD OR PARTICIPATE IN CROSS-FUNCTIONAL TEAMS AS THE BIOOPS SM REPRESENTATIVE TO PROVIDE SUBMISSION RELATED EXPERTISE • LEAD THE PROCESS OF CRITICAL REVIEW OF CMC REGULATORY DOCUMENTS AND INCORPORATING MULTIPLE INTERNAL AND EXTERNAL REVIEWS INTO QUALITY DOCUMENTS • MANAGE SM ACTIVITIES ASSOCIATED WITH MULTIPLE PROJECTS: DELIVERY OF DOCUMENTS TO SUBMISSION READY STANDARDS • PARTICIPATE OR LEAD TEMPLATE AND PROCEDURE PREPARATIONS • PARTICIPATE IN SM-RELATED WORKSTREAMS WITHIN AND ACROSS DEPARTMENTS • ASSISTS IN PROVIDING ANGEL BUSINESS SUPPORT AND TRAINING TO BIOLOGICS OPERATIONS NETWORK • LEAD OR PARTICIPATE IN PROCESS IMPROVEMENT INITIATIVES. • WORK WITH REG CMC, BPD SUBMISSION MANAGEMENT AND THE GTO PRODUCT CHAMPION TO ENSURE SEAMLESS TRANSFER OF SUBMISSION MANAGEMENT RESPONSIBILITIES FOR POST APPROVAL SUBMISSIONS AND WAVE 2+ MARKETS MINIMUM REQUIREMENTS: • BS/MSc in a scientific discipline relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc. • 6+ years of biopharmaceutical industry experience, including 2 years of writing experience in a regulatory environment. • Experience preparing CMC regulatory documents and/or manuscripts is desired. • Background in biologics such as monoclonal antibodies and/or vaccines. • Must have strong interpersonal skills and an ability to influence. • Must be able to work on multiple projects at once. • Must be proficient in Microsoft Office. • Knowledge and understanding of FDA and EMA regulatory requirements and ICH guidelines. • Experience in working with Style guides and electronic submission systems. • Project management experience and a high level of organizational skills
Alten Sverige AB
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