Associate Director, Regulatory Science, CMC

Location:Oxford, GBCompany: oxfordbiomWe use science to save lives, and so can you.We are currently recruiting for an Associate Director, Regulatory Science CMC team. The purpose of this role is to develop and execute worldwide regulatory CMC strategies with our clients and to ensure regulatory CMC compliance for clinical development and commercial gene therapy products.We are happy to considerflexible home working arrangementscombined with some on-site presence.Responsibilities

Act as key CMC regulatory contact and interface with external and internal clientsand with global regulatory bodies.Propose and develop regulatory strategies with internal and external clients to meet pre-defined development milestones and goals.Write, review and manage CMC regulatory documentation for filing to regulatory agencies (including Module 3/IND/IMPD/ Quality Overviews).Coordinate and author CMC/quality responses to questions from regulatory agencies and external clients.Provide regulatory CMC input and direction into Agency communications including preparation of briefing documents for scientific advice and support / attendance at client Agency advice meetings.Provide regulatory review and sign off for technical change control and deviations in a timely manner.Support regulatory intelligence activities to ensure ongoing regulatory compliance.We are looking for

Bachelor’s degree in a life scienceCMC specific regulatory experience in the areas of biological and/or advanced therapy productsDirect experience with EU and US regulatory procedures and proven record of writing regulatory CMC documentationExperience of interactions with regulatory bodiesGood understanding of GMP regulations, preferably in the area of ATMPsComprehensive knowledge of regulatory guidelines affecting the quality, manufacturing and controls of biological and advanced therapy products.A client centric self-starter, able to work to tight deadlines with the ability to balance multiple projects and prioritiesWhat’s in it for you

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.What’s in it for you

Highly competitive total reward packagesWelcoming, friendly, supportive colleaguesA diverse and inclusive working environmentOur values are: Responsible, Responsive, Resilient, RespectState of the art laboratory and manufacturing facilitiesWe want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

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