Regulatory Affairs Asssociate

Regulatory Professionals
10 Oct 2018
14 Oct 2018
Contract Type
Full Time
Regulatory Affairs Associate Permanent Essex commutable from Hertfordshire & Cambridge Salary dependent on experience Job Reference: JO-1807-412322 A small bio-tech based near the Hertfordshire/Cambridgeshire border are currently going through a period of growth and therefore require a Regulatory Affairs Associate to assist on an initial MAA submission for an orphan indication. This role is perfect for a professionals with just over a years experience within Regulatory Affairs, but looking to gain exposure to a variety of different aspects in drug development. Key Responsibilities: - Assist where required on submitting initial MAAs for a new orphan drug - Support compilation and publishing of regulatory dossiers for the EU and US markets - Production of high quality regulatory documents to support competent authorities and pertain product life-cycle management - Regulatory input to the portfolio management and resource planning - Occasional assistance in pharmacovigilance and assist in setup of PV functions where requires Application Requirements: - At least 1 years experience within Regulatory Affairs and knowledge of submitting MAAs or CTAs to EU competent authorities - Pro-active attitude with excellent time management skills and the desire to get involved in multiple aspects of drug development - Knowledge of EU and/or US filings - An overall understanding of drug development research and development process - Candidate must be eligible to work within the UK If you meet the outlined requirements and are interested in this position then please feel free to send your CV to or if you have any questions regarding the role then please call 01189 522 797. If this role is not quite right for you, but youre interested in hearing about new career opportunities, then please still get in touch as further Regulatory roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully placed then youll receive 250 worth of vouchers of your choice.