Head of Regulatory Affairs
Due to growth and expansion my client has a vacancy for a Head of Regulatory Affairs specialising in licensed product regulations to ensure that all products comply with UK and international regulatory guidelines. You will work closely with the Director of Quality & Regulatory Affairs, Head of Research and Development.
- Lead, manage and motivate of the Regulatory Department team to ensure high standards are maintained at all times.
- supply monthly project updates to the Company Chairman and Directors.
- provide support to our International Distributors.
- give regular updates to the Divisional Directors’ and Company Chairman on regulatory changes and developments in the UK and overseas markets that may or do impact the company.
- set-up and complete required variations on licensed products to the VMD
- assist in the pharmacovigilance requirements of the company
- agree regulatory standards and ensure that there are clearly defined procedures for staff to follow and that these are understood and implemented.
- work closely with the Quality Department to ensure that all changes are made in line with current regulatory requirements.
- manage and maintain a system to track all relevant stages relating to registration and licensing.
- bachelor of Science degree (Pharmacy/Chemistry or related discipline) essential
- minimum five years’ experience in Regulatory Affairs, ideally in Veterinary Medicine and Animal Feed Regulations
- experience of working with regulatory bodies such as VMD or MHRA
- a good understanding of product registration in international markets
- relevant experience working within a GMP compliant company preferably in a Quality role preferred Good interpersonal skills