The BioOperations Submission Manager will work within Global Technical Operations (GTO) and, work with BPD and BioOperations 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.
- Responsible for BLA/MAA delivery and life cycle management working within Global Technical Operations
- Lead or participate in cross-functional teams as the BioOperations SM representative to provide submission related expertise
- Lead the process of critical review of 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 BioOperations 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
- Assist the Product Champion with change management processes, communication and Post Approval CMC Team Leadership
- BS/MSc in a scientific discipline relevant to manufacturing and drug development, such as cell culture, purification, analytical biochemistry, formulation, etc.
- 6+ years of biopharmaceutical industry experience, including 2 years of writing experience in a regulatory environment.
- Experience preparing CMC regulatory documents and manuscripts is desired. Expertise in electronic submissions, requirements for submission-ready documents, and regulatory requirements for submission approval is required. RA certification is desirable.
- Background in biologics such as monoclonal antibodies and/or vaccines.
- Must have strong written and oral communication skills.
- Must have strong interpersonal skills and an ability to influence.
- Must be able to work on multiple projects.
- 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 and a high level of organizational skills