Kendle has an immediate opening for a Senior Regulatory Affairs Consultant to join the team based from the Camberley, Surrey location.
The Senior Regulatory Affairs Consultant position is suited to individuals with a high level of technical expertise.
The position is responsible for providing advice and assistance to clients and other Kendle associates in their areas of expertise.
This position will work closely with the Regulatory Group Leaders / Associate Director(s) on technical issues and support new business development.

Accountable for performance on major projects.
Work independently and with Principal Consultants and Project Managers assisting clients with regulatory advice and strategies.
Provide general, development and regulatory advice to both clients and Kendle associates.
Responsible for completion of assignments on time to cost and quality requirements, with a proactive approach to assignments.
Contribute to time and cost estimates for projects.
Act as primary point of contact for specific clients and regulatory authorities as required.
Develop an area of special skill and provide an in-house resource as required.
Assist in training staff within Operating Units and Kendle globally as required.
Arrange, participate and report on client meetings with managerial input as necessary.
Arrange, participate in and report on meetings with regulatory authorities, with managerial supervision.

We are interested to review applications from individuals qualified with a relevant scientific degree, or equivalent. This qualification should be further supported by combined pharmaceutical and management related experience and a proven track record of managing the preparation of regulatory submissions including IND, NDA, MAA, CTD and European clinical trial applications.
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.
Additional skills and knowledge required include:
Sound and current regulatory knowledge, with an understanding of the critical path of pharmaceutical product development.
In depth knowledge of specialty or broad general knowledge of registration and competence in all aspects of dossier production (QSE).