Clare Henneberg

Responsible for the coordination, strategy and writing of all ESSITY/BSN Clinical Evaluation Reports (4 therapy areas, 5 Legal Manufacturers, Class I-IIb) to meet MDR requirements.

Responsible for global regulatory activities related to drug eluting coronary stent delivery systems.

-strategic and operational regulatory activities for the whole UK Vaccines Portfolio (Paediatric, Travel & Flu) - 3 direct reports - licence activities for the Respiratory and Metabolism product porfolios - National, MRP, Centralised licences (Variations, Safety Updates, Labelling, etc) - development compounds (Clinical Trial Applications) - dispensing devices - Established relationships with the MHRA including attendance at Scientific Advice meetings

- Initial set-up and management of the Regulatory Affairs Department for the UK and Republic of Ireland - Staff recruitment and writing departmental Process Guides and SOPs - Management of National and MRP licence activities for GI products (Variations, Clinical Trial Applications, PSURs, etc.) - submission of a NCE via the Centralised Procedure, including attendance at the Executive Summary Meeting with the IMB, subsequently nominated as Rapporteur - Coordination of pre-launch planning of NCEs

- Part of the team responsible for the simultaneous submission (MAA & NDA) of a NCE - Responsible for the preparation of National and MRP submissions for international markets - Co-ordination and participation in the review of the Clinical and Non-Clinical Modules and Expert Reports