Regulatory Affairs Manager

Job Ref: J26661
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 15 May 2018
  • Edinburgh, Scotland, UK
  • Competitive
  • Neal Panting
  • 01753 589601

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My Client a Global Healthcare company has opened a new vacancy within their Regulatory Affairs team. They are actively seeking to recruit a Regulatory Affairs Manager to work at their offices in the Scotland.

The Role:

The Regulatory Manager Vaccines is an integral member of the regulatory affairs team, leading registration of selected veterinary medicinal products for the global marketplace. This role has a speciality in vaccine development and registration and provides training and support to other members of the regulatory team. This role provides support to the Head of Regulatory Affairs (HRA) and advises the R&D department on the development of veterinary vaccine products to gainRegistration's in the EU, USA and other important global markets. The role requires the preparation and submission of regulatory dossiers and the maintenance of existing products. The Regulatory Manager Vaccines reports to the Head of Regulatory Affairs.

Key Responsibilities:

* Providing strategic regulatory advice to project development managers and other R&D staff on the development of new veterinary medicinal products* The prepare of e-dossiers and submission documentation for the registration of veterinary medicinal products globally* Life cycle management of registered veterinary medicinal products* Providing key advice and training to other regulatory staff on veterinary vaccines* Provide regulatory intelligence in key regulatory environments* Provide input into the development of regulatory systems and documentation management* Interfaces with technical teams on the progress of regulatory aspects of R&D projects* Communicates ideas for improving company regulatory processes with a positive and constructive attitude, and for developing this attitude in others

Skills/Experience Required:

* A broad depth of experience in regulatory affairs within the animal health sector essential* A proven track record in the registration of veterinary medicines in the EU and key global markets* Experience in veterinary vaccine registrations essential* Knowledge of the European registration routes (centralised, DCP and MRP) a requirement* Knowledge of FDA and/or USDA registration an advantage* Educated to degree level, preferably in biological sciences. A higher degree or specific relevant work experience highly desirable* Knowledge and understanding of product development processes and knowledge of GCP, GLP and GMP would be an advantage

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

14/06/2018 10:38:19