Biologics Operations Submission Manager, AstraZeneca

Job description
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. This is a consulting positon at AstraZeneca.

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


Qualifications
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

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-05-11, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information, please contact Linnea Öster linnea.oster@randstad.se

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!