Job Description

The role of regulatory affairs manager will be to provide an expert scientific consultancy and regulatory service to clients for pharmaceuticals and related areas by assisting with identifying and processing potential sources of business into projects with revenue.

You must be able to multitask as well as work independently. The role will be directly responsible for achieving agreed revenue targets for assigned project work and thus have a direct impact on the revenues of the group.

You will be assisting in developing new and supporting existing client relationships and acquiring revenue-earning projects. The role will also require you to review and critically assess regulatory and/or safety data and provide expert advice and guidance both internally and externally.

Decision making - you will be responsible for making decisions, and forming opinions on scientific and regulatory issues and provide strategic comments within sponsored projects and to communicate these orally and in writing to the client. To organise and manage regulatory documentation, literature/safety data reviews and position papers.

To support the provision of the necessary documentation and services to the required standard and in a timely fashion.

To maintain expertise in appropriate scientific disciplines through participation in relevant scientific and regulatory meetings.

Assist in the training of junior staff within the group.

To comply with Quality Standards.


• Degree educated
• Previous experience amounting to 5-7 years in preclinical drug development gained within industry, academia or contract research or approx.
• Excellent communication skills.
• Proven ability to demonstrate communication/interpersonal skills necessary for client contact and the potential to develop in sales/business development.
• Excellent planning and organizational skills.

Qualifications/Skills Required

Regulatory Affairs Manager