Kendle is actively recruiting a Director of Regulatory Consulting, Europe to be office based from the Camberley, Surrey offices.
The Director of Regulatory Consulting, Europe is responsible for leadership and direction of the Regulatory Consulting functions within Europe. This responsibility includes close working relationships with members of the regulatory department, other regulatory locations, Kendle Operating Units and clients.
The Director is responsible for the day to day functioning of the unit through Europe and its business and operational development, both as a profit centre and as an integral part of Kendle in line with corporate strategic objectives.

The Director is responsible for building and maintaining the budget for the group and for maintaining the quality and consistency of the group’s service to clients.
Core Responsibilities Provision of strategic leadership for the European Regulatory function to achieve the company’s mission, department goals and creating value for customers.
Development and execution of the long term strategic business plan for the EU Regulatory Group, and determine staffing/resource requirements for the group.
Responsible for the building and maintenance of the budget for the EU Regulatory Consulting Group.
Influence overall objectives of the regulatory function within Europe but also globally and on regulatory aspects of the clinical function.
Accountable for the day to day running of the European Regulatory Consulting group, ensuring quality and having ultimate responsibility for all projects undertaken by the group.
Contribute to the selection of staff for bid defence meetings and attend bid defence meetings and business generation tours for both Kendle multi-service and stand alone regulatory projects.
Contribute to and review costings for both Kendle multi-service and stand alone regulatory projects.
Interpret and communicate Company Policy within the EU Regulatory Consulting Group.
Act as a key point of contact for clients, regulatory authorities and senior managers within the Kendle organisation.
Act as a resource for industry knowledge and technical knowledge.
Contribute to the completion of organizational projects and goals with a specified time frame.
Provide general, development and regulatory advice to both clients and Kendle associates.
Participate in and contribute to training programmes and train staff within the EU Regulatory Consulting Group, and Kendle globally as required.
5% of time should be spent on billable client work.

Applications for this position are invited from candidates who are qualifiied to degree level (or equivalent).
This should be further supported by combined pharmaceutical and management related experience, Regulatory experience and previous proven experience in managing the preparation of regulatory submissions including IND, NDA, MAA, CTD and European clinical trial applications essential.
A Post-graduate degree (or equivalent) is desirable.
Experience in the management and preparation of electronic submissions and systems is desirable. Experience of working in an independent office environment, knowledge of the CRO industry, and strong management experience in a complex multi-process oriented environment in general is strongly desired.
Excellent leadership and decision making skills are required.