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Shionogi Europe
,
London, Greater London
Regulatory Affairs Manager
Overview
Job Description
Description Being innovative, thinking differently, collectively working together are all fundamentals of our culture. By putting patient's first and working to our values, we have recently gained marketing approval for two new products. With new indications and projects in the pipeline, we are looking for an EU Regulatory Affairs Manager to be part of our successful team. In this position you will be responsible for complex scientific post approval projects, working to manage EMA queries and answer questions. With the Regulatory Strategy Lead you will work cross functionally with colleagues in Japan/ US/ EU to inform and influence. Also, you will have the opportunity to be involved in new development projects as they come through our pipeline. As part of your responsibilities you will: * Support post-marketing licensing requirements and ensure effective liaison across the organisation to optimise regulatory strategies * With support lead responses to review queries from Health Authorities * Assume ownership and responsibility for regulatory projects, working collaboratively with stakeholders internally and externally * Mentor/instruct and provide guidance to internal and external parties, including consultants and CRO's; plan, assign and direct work as needed; manage competing priorities as appropriate * Support the improvement of department working procedures and other departmental initiatives as needed. * When appropriate manage the CTA submission process and ensure successful approval of CTA applications, define CTA strategies, including appropriate oversight and management of CRO vendors For this position we need you to have excellent EU post approval experience, this will include: * Experience of post-marketing regulatory affairs, including variations and life cycle management through European procedures (CP, DCP, MRP) * Experience of clinical, labelling and PV amendments and changes * Ability to work well within a matrix environment, build team relationships and interface in a global team environment at all levels of management * Proven ability to plan, effectively coordinate and lead activities simultaneously on multiple projects, many with tight time deadlines * Ideally some experience in EU regulatory submissions, with specific experience of clinical and non-clinical submissions to Health Authorities To be successful at Shionogi you will be a team player, have great communication and interpersonal skills and be resilient. If you can make a difference, please apply. At Shionogi Europe, we are a growing, dynamic company where everyone makes a real difference. We have the backing of Shionogi & Co Japan, with 140 years of success in the pharmaceutical industry, allowing us to be innovative as well as having an impressive pipeline.