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Turner Regulatory
,
London, Greater London
Associate Director Regulatory CMC / Fast-growing Biopharma / Central London
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Salary: HASH(0x55803fcefd28) |
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Overview
Associate Director Regulatory CMC. Exciting Regulatory CMC role; this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London. Regulatory CMC Development in Phase III leading to an MAA – Centralised Procedure. General Biologics and Pharmaceutical experience are required. Rare Disease Products/Orphan Drugs. Europe and Switzerland focus. Matrix-management environment. Project Managing – this role is a combination of Strategy, Development and ‘hands-on’. IMPD’s and Module 3 Authoring. This is an excellent Regulatory CMC opportunity with significant possibilities for advancement within this exciting organisation. Experience in Biologics is essential for this role, as is Centralised Procedure. Project Management skills, along with a background and working knowledge of Regulatory Affairs Strategy, Tactics & Implementation, throughout Regulatory CMC Development and Registration. Geographical remit: Europe/Switzerland. There are several existing products in the pipeline; however, the candidate’s responsibilities will encompass taking an assigned product successfully through Phase III through to a successful BLA/MAA. Scientific Advice meeting experience. The candidate will have 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 CMC in Phases II to IV - IMPD’s and Module 3 Authoring etc. 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. CTD/Dossiers for MAA's (particularly Module 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 8 years. The candidate will demonstrate solid Project Management skills. This position is based Central London, and may require some travel, as necessary. Some flexible working is permitted. 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.