*Support global regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational, and provide input into relevant sections of development plans for assigned programmes.
*Support the Global Regulatory Companion Diagnostics (CDx) Lead to implement a successful co-development strategy that bridges across the assigned gene therapy(ies) and companion diagnostic(s).
*Ensuring preparation and submission of high-quality regulatory documents including, but not limited to, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance.
*Act as contact point for internal and external clients, including CROs and regulatory authority interactions.
*Responsible for the regulatory project management for assigned projects i.e. planning and tracking submission and approval timelines, regulatory commitments, etc.
*Contribute to the growth of the Function, including supporting GxP compliance and inspections and regulatory systems.
*Remain expert and up to date on global regulatory requirements including nonclinical and clinical aspects.
*Keep abreast of relevant regulatory intelligence and ensuring this is communicated, appropriately, across the Company.
*Assist with training of staff in regulatory matters as required.
Requirements
*Relevant degree in a life science / science discipline.
*At least 6-8 years' experience in regulatory affairs across various companies preferably in biotechnology/biologicals and/or rare diseases in a centralized European setting where US experience would be a bonus.
*Knowledge and understanding of EU and ICH guidelines and experience of working to GxP is essential. Awareness of US and Canada guidelines and understanding of the in vitro device/companion diagnostic regulations would be a bonus.
*Experience in the preparation of regulatory submissions during the lifecycle particularly INDs/CTAs, scientific advice briefing documents, PIPs and/or orphan designation applications or sections of the MAAs/NDAs and/or post-approval submissions.
*Interactions with the EMA and European national regulatory authorities required; any experience with FDA interactions would be a bonus.
*Demonstrated ability to create and drive an effective regulatory strategy and handle critical issues effectively with demonstrated creativity in solving regulatory issues.
