Role Summary

With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Senior Manager, Regulatory Affairs to join the Autolus team to work on innovative and pioneering products across Autolus’ cell and gene therapy portfolio in Europe. The Senior Manager, Regulatory Affairs will be part of the broader global regulatory affairs team with responsibilities for planning, preparing, reviewing and submitting regulatory applications to health authorities in Europe and globally.

The successful candidate will be working on innovative and pioneering Advanced Therapy Medicinal Products (ATMPs) in assigned disease areas and benefit from working with cutting edge technologies and be a key player in developing regulatory submissions and advancing Autolus’ innovative portfolio of products.

Key Responsibilities

• Is responsible for the planning, coordination, preparation, review and submission of regulatory applications and submissions (e.g PIP, Orphan Designation, Variations) in collaboration with the cross-functional team.
• Responsible for clinical studies as assigned including trial documentation development, document review and submission planning in collaboration with the Clinical Study Team and Regulatory Operations.
• Is responsible for the coordination, preparation, review and timely submission of responses to questions from Regulatory Agencies.
• Supports the approval process and maintenance of regulatory applications and registrations throughout the lifecycle of the assigned assets.
• Supports the planning, coordination, preparation and execution of regulatory agency meetings.
• Proactively supports development of regulatory strategies and executes agreed strategy.
• Identifies potential regulatory risks to the strategic / operational plans and proposes options to mitigate risks.
• May act as primary liaison with the concerned Regulatory Agency.
• Ensures appropriate and correct procedures are followed with regards to Advanced Therapy Medicinal Products (ATMP/ RMAT) and stays abreast of international requirements.
• Monitors the evolving treatment landscape and proactively provides updates and regulatory guidance to the development project and clinical operations teams.
• Stays abreast of cell and gene therapy regulatory intelligence.
• Supports cross-functional teams (e.g. Research, Pre-Clinical, Manufacturing, Clinical Operations) and liaises with external providers to ensure delivery of high-quality and timely regulatory submissions.
• Ensures regulatory activities comply with the Autolus Code of Business Conduct and Ethics, SOPs and Work Instructions.
• Any other duties as required following consultation with the post-holder.
• The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.