Head of CMC/Operations

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Head of Regulatory CMC and Operations I am currently working with an exciting Biotech in Hampshire who are looking for a Head of Regulatory CMC Operations to join the team.

As Head of Regulatory CMC and Operations, you will lead a team to deliver regulatory CMC, Operations and local market objectives on schedule and within agreed budget. You will provide innovative and compliant regulatory solutions to support the development and maintenance of products, aligned to the commercial and R&D business plan. Key Responsibilities:Develop, support and manage an expert team of Regulatory affairs CMC and Operations staff across EU sitesPlan and deliver strategies to meet business plan "R&D Roadmap" for the regulatory CMC, labelling and Operations aspects of development and approval of new drugs as well as commercial product life cycle management activities; be the primary point of contact for these activities to ensure effective communication between regulatory CMC/Operations and internal stakeholders including Manufacturing Operations, QA and CommercialManage and support the preparation of high quality, compliant CMC and life cycle maintenance dossiers including clinical trial IMPDs/ INDs, Marketing Authorization Applications, post-approval variations, renewals, PSURs and responses to agency requests for information across all regions, ensure timelines are met in accordance with project plansOversee local market requests and preparation of local dossiers to meet business objectivesManage regulation of all product marketing and promotional materials and programs to ensure scientific accuracy and adherence to regulatory guidelinesResponsible for the oversight of labelling preparation and the development and improvement of labelling processes for development and marketed productsKey Requirements:Experience in Regulatory Affairs (8 years minimum)Excellent knowledge of Regulatory Affairs submissions procedures, including hands on practical experience of reviewing and preparing submissions as well as submission project managementProven line management experienceExcellent knowledge of regulatory CMC for development and marketed productsExperience with management of change control processesExperience with regulatory systems and operation management preferredCurrent knowledge of legislation/guidelinesExperience of NPP, Specials or working in the Biologics field would be a distinct advantageIf this Head of Regulatory CMC and Operations role could be the next exciting step in your career, please don't hesitate to get in touch as soon as possible - the process is underway! To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales