REMOTE WORKING / Director, Regulatory CMC / Biotech / Strategy,

Director, Regulatory CMC – Fast–growing Biotech. Leadership, Strategy, Development, Registrations and Lifecycle management. Lead Scientific Advice meetings. Exciting Regulatory CMC position: this is a rare opportunity to join a fast–growing and dynamic Biopharma in a fantastic location in Central London; superb role. Regulatory CMC Development in Phases I, II to III, Registrations and some Post marketing activity. General Biologics is essential and some ADTHER experience highly desirable. Rare Disease Products/Orphan Drugs. Europe, USA, and international focus. Matrix–management environment. Project Leading – this role is a combination of Strategy, Development and 'hands–on.' Reporting to the VP Regulatory CMC, this is an excellent Regulatory CMC commercial opportunity with significant possibilities. Experience in Biologics is essential for this role. Project Management skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. Geographical remit: Europe and International/USA. There are a number of existing products in the pipeline hence the candidate's responsibilities will encompass taking the assigned products successfully through Phases I, II and III through to successful BLA's/MAA's. The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in Europe. The geographic scope of this role is Pan–European, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience, but with specific strengths in Development Regulatory Affairs in Phases II to IV. The company operates more on a matrix–management model hence the candidate must be prepared to be 'hands–on' and be heavily involved in the day–to–day management of Projects. The candidate will need to have a substantial background in both Strategy and Development Regulatory, ideally: IMPD's (CMC section); CTD/Dossiers for MAA's (authoring Modules 3 and 2.3); Post Marketing/Lifecycle Management: Type Ia, Ib and II Variations, Renewals, and Line extensions. EU procedures – particularly Centralised Procedure & BLA's; Regulatory Strategy, Tactics, and Implementation; lead Scientific Advice meetings with the EMA and FDA. A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA, FDA and other national Authorities would be an advantage in terms of company representation. The successful candidate will possess a solid Regulatory CMC background within Biologics of at least 8–10 years. The candidate will demonstrate superb Project Management skills. This position is based Central London with flexible working, and may require some travel, as necessary. A generous salary package is on offer for the right candidate, this will include a superb basic, excellent bonus and numerous other benefits. If you are interested in this, or any other Regulatory Affairs roles, please contact Julian Turner, at Turner Regulatory Recruitment, on / ; or apply by clicking Apply Now.