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Turner Regulatory
,
London, Greater London
Director Regulatory CMC, Gene & Cell Therapies / Top Biotech / London
Overview
Director, Regulatory CMC Gene & Cell Therapies – this fast-growing Biopharma is very patient focused with concentration on combating life-threatening rare genetic disorders. There is some flexibility regarding working arrangements. Experience in Biologics is essential for this role; Gene/Cell Therapy experience is ideal. Superb Senior Regulatory CMC role; this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London; outstanding role and a career-making challenge. Regulatory CMC Strategy, Clinical/Development in Phases I to III, Registrations and Post marketing activity. General Biologics experience is highly desirable. Rare Disease Products/Orphan Drugs. Europe and some International territories. Matrix-management environment. High-level Project Leading in addition to supervision of other staff – this role is a combination of Strategy, Development, ‘hands-on’ and people management. This is a superb Regulatory CMC opportunity with significant financial possibilities. High-Level Project Leadership skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. This individual will be responsible for the Regulatory Strategy of key products hence this is a very important hire. Geographical remit: Europe/Switzerland – knowledge of USA/FDA and other International territories would be beneficial but not necessarily essential. Reporting to the VP of Regulatory CMC, this position manages Leading Projects within a matrix-management environment. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have a good perception of how Regulatory CMC issues can impact on profitability and ‘bottom-line’. There are several existing products in the pipeline hence the candidate’s responsibilities will encompass taking the assigned products successfully through Phases I to III through to successful BLA’s/MAA’s. The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep 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 Clinical and Development Regulatory Affairs in Phases I to IV. Although there are internal and external individuals to supervise and manage, 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: CTA’s/IND’s, IMPD's (CMC sections), IB's, Protocols, up-dates/amendments and End of Trial Notifications – in conjunction with the management of CRO’s when necessary. CTD/Dossiers for MAA's (particularly authoring 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. PIP's. 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 substantial Regulatory Affairs CMC background within Biologics of at least 10 years. The candidate will demonstrate superb Management and Project Leading skills along with mentoring of staff and the ability to develop and expand a team when necessary. This position is based in Central London and may require some travel as can be expected with a role of this seniority. A significant salary package is on offer for the right candidate, this will include a superb basic, LTI’s, excellent bonus and numerous other benefits. There is some flexibility regarding working arrangements. 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.