Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.
Due to our continued growth we are looking for a Senior Regulatory Affairs Manager - CMC to join our CDS team. The purpose of this role is to develop and execute Regulatory CMC strategies for gene therapy products in clinical development and commercial products primarily in the EU and US markets (pre- and post- approval)
Key responsibilities and accountabilities:
Support product development teams in all aspects of regulatory CMC and provide input into relevant sections of development plans.
Write, review and manage CMC regulatory documentation for filing to Regulatory Agencies (including Module 3/IND/IMPD). Co-ordinate and author CMC /quality responses to questions from Regulatory Agencies and external clients.
Provide regulatory CMC input into Agency communications including preparation of briefing documents for scientific advice and act as contact point for CMC/quality regulatory questions / issues for internal and external clients including regulatory agencies
Provide regulatory input into technical change controls in a timely manner.
Maintain CMC document management and quality of submissions to support regulatory compliance.
Support regulatory intelligence activities.
Key skills and requirements:
Bachelor’s degree in a life science, preferably with a PhD in a pharmaceutical science
Demonstrable CMC- specific regulatory knowledge (EU/US/ICH and other relevant guidance) & experience within biotechnology
Direct experience with EU and US regulatory procedures and ability to write Regulatory CMC documentation
Creation and execution of regulatory strategies for EU and US regions
Good understanding of GMP regulations, preferably in the area of ATMPs
Comprehensi ve knowledge of regulatory guidelines affecting the quality, manufacturing and controls of biological and advanced therapy products
Fluent in English (spoken and written)
Be able to work in a fast-paced environment with internal and external stakeholders