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Job Details

Director Regulatory Development & Strategy, Gene / Advanced Therapies / London

Company: Turner Regulatory
Location: London
Reference: 10108-2
Closing Date: 01 Apr 18
Type: Permanent
Salary (£): 100,000+
Benefits: Significant package; great salary, bonus, LTI's other benefits

Job Summary:

Director or Senior Director Level; New Biotech Company; Regulatory Strategy & Development; Gene & Advanced Therapies; EU & USA focus; Matrix environment; Central London location


Sensational Senior Regulatory role; this is a rare opportunity to join a relatively new entity; superb role and a career-making challenge. Clinical and Development Regulatory activity. Biologics and Gene/Advanced Therapy experience highly desirable. Rare Disease Products/Orphan Drugs. USA and Europe focus. Matrix-management environment. PIP's and Scientific Advice meetings.

This is effectively is a start-up opportunity with significant financial possibilities. Experience in Biologics is essential for this role. Leadership skills are vital, but a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, particularly in Clinical/Development Phases II & III leading to and including BLA's/MAA's is also important.

This individual will be responsible for the Regulatory Strategy of a few key products hence this is a very important hire. Geographical remit: USA/FDA and Europe. Reporting to the Global Head of Regulatory Affairs, this position has a small number of reports in Europe within Regulatory Affairs. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have a good perception of how Regulatory issues can impact on profitability. 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 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 the USA and Europe. The geographic scope of this role is USA and 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. Although there is a small team to manage, the company operates more on a matrix-management model.

The candidate will need to have a substantial background in Clinical/Development Regulatory Affairs and a good understanding of Project Leadership, ideally: IND's, CTA's, VHP, IMPD's, IB's, Protocols, up-dates/amendments and End of Trial Notifications. CTD/Dossiers for NDA's/MAA's (all Modules); National Submissions/MRP, DCP and particularly Centralised Procedure; Regulatory Strategy, Tactics and Implementation; Regulatory Intelligence, Scientific Advice and EOP2 meetings - the FDA and the EMA, and PIP's. A demonstrable working relationship with the major Regulatory Agencies and contacts within the FDA and EMA would be an advantage in terms of company representation.

The successful candidate will possess a substantial Regulatory Affairs background within Biologics or Advanced Therapies of 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 can based in Central London, or the USA East Coast, and requires 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, excellent bonus and 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 9477/07447 977 330,, or submit an application by clicking Apply Now.

Apply for this job: Director Regulatory Development & Strategy, Gene / Advanced Therapies / London

Contact Information:

Address:  Head Office
71-75 Shelton Street
Covent Garden
Tel:  0203 695 9477
Website:  Visit Our Web Site

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