AstraZeneca Pharmaceuticals LP Bio Operations Submissions Manager - Global Biologics Operations in Gaithersburg, Maryland

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Functions as a member of the BioOperations Submission Management (SM) team within Global Technical Operations (GTO) and, working with BPD and BioOperations scientists, manages the preparation and review process of regulatory documents for the quality (CMC) modules. As a member of the SM team, coordinates and consults on regulatory filings and writing processes; identifies and promotes initiatives to advance the AstraZeneca biologics pipeline and support marketed products.

Main Responsibilities

  • 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

Education/Experience:

  • 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.

Special Skills/Abilities:

  • 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

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.