Regulatory Affairs Lead

2 weeks ago

East Coast, Singapore Autolus Ltd Full time

With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced US Regulatory Affairs Lead to join the Autolus team to expand their cell and gene therapy products in the United States (US).
Key Responsibilities
- To provide strategic US regulatory input into clinical development and ensure the development and implementation of appropriate risk-based regulatory strategy and policies in line with the global regulatory strategy;
- To identify potential US regulatory risks to the strategic / operational plans and propose options to mitigate risks;
- To plan, prepare, manage and lead scientific advice meetings and other appropriate interactions with the FDA (e.g. pre-IND, pre-IDE, EOP1/2, pre-BLA meetings) to increase the predictability of regulatory outcome and to provide the best regulatory platform to support marketing approval and market access;
- To prepare high quality, detailed regulatory documents using varied information sources, engage in technical writing and gather prevalence and incidence data as appropriate;
- To draft US labelling in line with regulatory requirements and emerging data and lead negotiations with FDA;
- To perform regulatory review of essential documents, ICH GCP review of submission documentation e.g. protocol, IB, ICFs, labelling, human gene therapy protocols etc. and administrative activities such as eTMF filing;
- Ensure compliance with National/US Regulations and ensure awareness of cell and gene therapy guidelines across the company;
- Liaise with cross-functional team members in Translational Research, Product Delivery, Clinical Operations, Clinical Development, Project Management and external providers to ensure timely and effective regulatory submissions in support of product progression;
- To be responsible for development and training of US staff in regulatory matters and to communicate the impact of new regulatory requirements across the Company.

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