We are currently recruiting for experienced Regulatory Specialists to work in this large manufacturing business.
The main purpose of the role is to support validation activities associates with the delivery of product transfer project work. The positions are intended to be for a fixed 2 year period (with flexibility to extend). The roles will be part of a team supporting site transfer projects from one facility to another.
The key tasks for the regulatory specialist’s roles are:
• Working with cross functional teams to develop project plans and ensure adherence to schedules and project deadlines
• Development and update of design dossiers and technical files
• Conduct and facilitation of risk management activities
• Identification of regulatory impacts and execution of registrations in all territories impacted
• Management of interfaces with third party organisation within project responsibilities
• High standard of technical report writing
• The ability to read, analyse and interpret scientific and technical reports and respond to enquiries from regulatory agencies.
We are looking for the following qualifications/experience for the Regulatory Specialist roles:
• The ideal candidate will have a degree in Engineering/Biological sciences discipline, or equivalent
• Demonstrate a thorough understanding of RA practices and procedures within a regulated industry. This should include experience with regulatory filings and requirements in one or more of the following key markets – EMEA, Candida, USA, Australia, Japan, China, India, Brazil)
• Thorough understanding of main markets and 93/42/EEC M5 updates is essential
• Proven track record in risk management is essential
• The ability to project manage using industry recognised tools
• Domestic and international travel may be required.
In return, my clients are offering a salary of between to £30 - 35k pa plus company benefits.
To be considered for the Regulatory Specialists role’s, we are looking for applications from candidates with the above experience from within either a medical devise, pharmaceutical or a highly regulated industry.
This is initially a two year fixed contract role with a retention bonus to be paid on project completion.
To be considered for this role, please send your CV and covering letter today.
Company Description
Mobius Resourcing is an Independent Recruitment Consultancy specialising in the introduction of staff for Permanent positions on a national level.
