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Turner Regulatory
,
London, Greater London
Senior Regulatory CMC Manager / Fast-growing Biotech / Central London
Overview
Senior Manager Regulatory CMC - Strategy & Development. Exciting Regulatory CMC role; this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London; superb role. Regulatory CMC Development in Phases II to III, Registrations and some Post marketing activity. General Biologics and Pharmaceutical experience highly desirable. Rare Disease Products/Orphan Drugs. Europe and Switzerland focus. Matrix-management environment. Project Managing – this role is a combination of Strategy, Development, ‘hands-on’. This is an excellent Regulatory CMC opportunity with significant possibilities. Experience in Biologics is desirable but not necessarily 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/Switzerland. There are a number of existing products in the pipeline hence the candidate’s responsibilities will encompass taking the assigned products successfully through Late Phases II and III through to successful BLA’s/MAA’s. The candidate will have particular expertise in Regulatory Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in Europe and Switzerland. 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 Development Regulatory, ideally: IMPD's, IB's, Protocols, up-dates/amendments and End of Trial Notifications – in conjunction with CRO liaison. CTD/Dossiers for MAA's (particularly Modules 3 and 2.3); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics and Implementation; Regulatory Intelligence, Scientific Advice meetings with the EMA. A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA 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 or Pharmaceutical of at least 6 years. The candidate will demonstrate superb Project Management skills. This position is based Central London, 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 get in touch with Julian Turner, at Turner Regulatory Recruitment, on 44 203 695 9477/44 1582 290 636; 44 7447 977 330, or julianturnerregulatory.com, or submit an application by clicking Apply Now.