An opportunity to work for a speciality generics and pharmaceutical company has arisen in the field of regulatory affairs. This company is looking for a new regulatory affairs project manager to be responsible for a wide range of technical regulatory affairs issues.
If you are looking for a stimulating role where you get to be part of a specialist team, read on to find out what you would be responsible for:
? Submitting and responding to HA RFI?s for type 1A/1B variations.
? Preparation and submission of label and leaflet self certification changes and variation to support manufacturer changes.
? Management, documentation associated tasks to support QP PV processes.
? Arranging GMP audits.
? Manage MA renewals and dossier preparation support.
? Maintain and update regulatory requirements.
? Manage regulatory projects.
Skills and Qualifications
? A minimum HND qualification in scientific discipline, ideally, will have a degree.
? Experience (3+ years) of working in a regulatory role within a pharmaceutical environment would be an advantage.
? Full working knowledge of product licensing requirements would be an advantage.
? Computer literacy
We are looking for confident and organised individual with excellent attention to detail, interpersonal, written and communication skills. If you fit the bill then this might just be the opportunity for you.
This company?s ability to provide a first class service, providing critical advice to its custromers has helped to launch hundreds of new generics onto the world market. If you want to be part of their vision as they move to the forefront of the industry, apply today.
For more information regarding this role, please contact Katy Bloom at Paramount Recruitment on 0121 616 5037.
Location
South-East, Berkshire, Reading, Bracknell.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.