Head of RA

Job Description

 

Head of Regulatory Affairs  

Location: Lancashire

Type: Permanent 

Salary: £55,000

 

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.

 

Responsibilities:

  • 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.

 

Requirements:

 

  • 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