Biologics Operations Submission Manager
Poolia Sverige AB - Göteborg - Publicerad: 2021-05-03 14:47:47
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives – and are made to feel valued, energized and rewarded for their ideas and creativity.
We are now recruiting a Biologics Operations Submission Manager to join AstraZeneca.
The Biologics Operations Submission Manager (BioOps 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 AstraZeneca biologics pipeline and support marketed products.
Dina arbetsuppgifter i huvudsak
• 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
Vem är du?
• 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
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status or any other characteristic protected by law.