Operations Regulatory CMC - Manager

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives – and are made to feel valued, energized and rewarded for their ideas and creativity.

Do you have a background in biologics, such as monoclonal antibodies and/or vaccines as well as experience with CMC regulatory documentation? Are you a project manager with strong collaborative and communicational skills? Then, this may be the perfect position for you!

Om tjänsten
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
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

Vem är du?
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

Om verksamheten
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.

This is a consultant assignment at AstraZeneca for 6 months time and with possibilities of extension. During the period of the assignment you will be employed by Poolia.

Submit your application today! If you have any questions regarding the consultant assignment feel free to contact Robin Öz.