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Job Details

Senior Director, Regulatory Affairs / European Head - Netherlands

Company: Turner Regulatory
Location: Netherlands
Reference: 10083-2
Closing Date: 31 Aug 17
Type: Permanent
Salary (£): On Application
Benefits: Car allowance, good bonus and leading benefits

Job Summary:

Leadership of the European Regulatory Affairs Team. Significant Regulatory Experience. Vaccines (ideal) or Biologics experience.

Requirements:

Exclusive role; this is a rare opportunity to lead European Regulatory Affairs for a relatively new entity – superb role and a career-making challenge.

This is effectively is a start-up opportunity with a difference. Experience in Vaccines (ideal) or Biologics is essential for this role. Leadership skills are vital, but a background of working knowledge and experience within Regulatory Affairs including past authoring is equally important. This individual will be responsible for the European Regulatory Team hence is a key hire. Geographical remit – Europe.

Reporting to the Vice President Global Regulatory Affairs, this position has direct reports in Europe within Global Regulatory Affairs. The candidate will oversee Core Regulatory/Global Project Leads, Manufacturing, CMC and Compliance and Operations in a number of sites in different countries. Budget and P & L responsibility, Cost Control, and high-level management liaison. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have good  perception of how Regulatory issues can impact on profitability.

There are a number of existing products in addition to the new product pipeline, although the first challenge is to maximise the commercial possibilities of mature products within Europe.

The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep understanding of Core Regulatory Affairs worldwide. The geographic scope of this role is Pan-European, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience.

Although Line management responsibility is the key to the role, the candidate will need to have a significant practical background in Regulatory Affairs and a good understanding of Project Leadership, ideally: Clinical, non-Clinical and CMC. CTA's, VHP, IMPD's IB's, Protocols, up-dates and End of Trial Notifications. CTD/Dossiers for MAA's (all Modules); National Submissions/MRP, DCP and Centralised Procedure; Post Marketing/Life-cycle maintenance: Type Ia, Ib and II Variations, Renewals and Line extensions; Labelling, PIL's and SmPC's. Regulatory Intelligence, Scientific Advice meetings and PIP's. Promotional material. A demonstrable working relationship with the major Regulatory Agencies and contacts within would be an advantage in terms of company representation.

The successful candidate will possess a substantial Regulatory Affairs background within Vaccines or Biologics of 10+ years. The candidate will demonstrate superb management skills along with mentoring of staff and the ability to develop and expand a team.

This position can based in Berkshire or Amsterdam 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, car allowance, bonus and other benefits including long-term incentives.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on the numbers provided, Email, or submit an application by clicking Apply Now.

Apply for this job: Senior Director, Regulatory Affairs / European Head - Netherlands

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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