EU Regulatory Affairs Director
Role Responsibilities: * Involved with development of regulatory strategies for new products. * Undertake co-ordinating role to prepare for, attend and provide regulatory expertise at regulatory authority meetings * Prepare and submit CTAs, orphan drug designations and MAAs to meet company goals and timelines * Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and adherence to regulatory standards. * Maintain current knowledge of relevant EU regulations including proposed and final rules. * Act as a company expert in EU Regulatory Affairs, providing updates, support and education as required * Provide EU regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. * Liaise with external collaborators and manage external resources e.g. CROs * Contribute to the establishment of the global regulatory function and organisation of company regulatory data * Play an instrumental role in the global regulatory affairs function through active participation and collaboration Demonstrated skills and competencies: * Extensive experience in EU Regulatory Affairs including significant industry experience (experience in Global territories is desirable) * Scientific qualification – minimum Bachelor’s Degree (post graduate qualification preferred) * Experience in immunology, cell/gene therapy or oncology advantageous * Regulatory experience with new product development for biotechnology products. * Thorough understanding of EMA and national European regulation * Management of external resources and liaison with external collaborators If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.