Senior Director/Director Regulatory Affairs Europe - Belgium

This is a great opportunity to join the management team of a leading pharmaceutical company. It is a role that requires extensive and robust experience in leading drug development and post-marketing regulatory activities at a European level, coupled with a proven track record in effective leadership and management of regulatory professionals.

We are looking for candidates that can bring considerable value and experience to what is an already highly experienced team of regulatory people. You will provide regulatory guidance on the development and presentation of product registration data so as to ensure timely registration of new products and new claims in Europe and as to ensure optimal maintenance of existing products. Troubleshoot and resolve any problem on the critical path to product registration. You provide regulatory liaison for European regulatory managers in the execution of regulatory strategies and drug registration activities and thereby ensure earlier product license approvals.

• Provide European-based regulatory guidance and liaison for all products developed by the company.
• Provide regulatory liaison role needed to initiate and maintain development of company products in Europe within the European Union regulations/guidelines.
• Provide guidance and support for assembly and presentation of dossiers for registration of company products
• Register all products in Europe and ensure optimal maintenance of existing products.
• Review all documents submitted to any European Agency on behalf of the company, assuring quality and adequacy of such documents.
• Maintain close interface between Regulatory Affairs Europe, Worldwide Regulatory Affairs and Analytical Sciences (VRAS), coordinating submission efforts with regulatory liaison departments to European Agencies.
• Support and provide EU regulatory input in relevant product teams (JPT, GRT,…).
• Monitor, in cooperation with WWRA-VB, the progress of preclinical and clinical activities to assure that European product registration requirements are met. Ensure, via the appropriate project teams and WWRA that these scientists fully understand European regulatory requirements.
• Consult, in cooperation with WWRA, with the Clinical Research Department in the development of clinical protocols pertinent to company regulatory needs.
• Identify and track changes/trends in the medical practice and attitudes within European countries that might impact his/her project and product responsibilities.
• Operate as a member of Regulatory Affairs Europe on internal policy and operating procedures and issues.
• Maintain a sound knowledge of specific diseases within therapeutic areas. Attend appropriate outside meetings and courses to maintain competency and awareness in his/her product area, international regulatory activities, and the pharmaceutical industry at large.
• Directly supervise a staff

Qualifications:

• M.D. or PhD in biological science, chemistry or related discipline required. Other doctoral degrees with substantial experience in regulatory affairs and administration as to suggest equivalent ability to function in this position
• M.D with more than 9 years relevant drug development experience required; PhD with more than 14 years relevant drug development experience required.
• Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
• Good management, communication, interpersonal and negotiating skills are also required to perform job duties effectively

If you feel that this position presents the opportunity for you to apply your current skills and experience and to contrbute to the direction and leadership of the function in Europe, we would very much like to speak with you and discuss this role in more detail as well as review your experience. Please contact us on +44 (0)20 7370 6451 or email us your Cv on careers@liftstream.com. You can also submit your CV through our website.

This position is now closed - November 21st 2008