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Job Details

Regulatory Affairs Director / EU & International / 'Cutting-edge' Biotech / Central London

Company: Turner Regulatory
Location: London
Reference: 10114-1
Closing Date: 09 Jun 18
Type: Full Time
Salary (£): 100,000+
Benefits: Car allowance, good bonus and leading benfits

Job Summary:

Regulatory Affairs Director; Leadership skills; Full Regulatory Pipeline experience; EU & International in scope; 'cutting-edge Biotech; Central London

Requirements:

Superb Senior Regulatory role for a ‘cutting-edge’ Biotech in Central London; this is a rare opportunity to join a company at the cutting-edge of science; superb role and a career-making challenge. Full pipeline Regulatory activity. Biologics experience highly desirable. Rare Disease Products/Orphan Drugs. Hepatology experience an advantage. Europe and International focus including the Emerging Markets. This role will Develop and Implement sound National and International Regulatory Strategies in collaboration with US based Global Regulatory Strategy Leads and local participants.

Experience in Biologics is desirable 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 leading to and including BLA’s/MAA’s is also important. This individual will be responsible for the Regulatory Strategy of a number of key products hence this is a very important hire. Geographical remit: Europe and International.

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 Europe. The geographic scope of this role is Pan-European and International, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience.

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, Registrations and Post Marketing and a good understanding of Project Leadership, ideally: CTA's, VHP, IMPD's, IB's, Protocols, up-dates/amendments and End of Trial Notifications; CTD/Dossiers for MAA's (all Modules); National Submissions/MRP, DCP and particularly Centralised Procedure; Regulatory Strategy, Tactics and Implementation; Regulatory Intelligence, Scientific Advice with the EMA, and PIP's. A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA would be an advantage in terms of company representation.

The successful candidate will possess a substantial Regulatory Affairs background ideally within Biologics of 10+ years. If the candidate has Hepatology experience this would be deemed an advantage. 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 requires travel as can be expected with a role of this seniority (approximately 20%).

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/+44 7447 977 330; julian@turnerregulatory.com, or submit an application by clicking Apply Now.

Apply for this job: Regulatory Affairs Director / EU & International / 'Cutting-edge' Biotech / Central London

Contact Information:

Address:  Head Office
71-75 Shelton Street
Covent Garden
WC2H 9JQ
England
Tel:  0203 695 9477
Website:  Visit Our Web Site

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