|Job Title:||Regulatory Affairs Associate|
|Salary:||£35000 per annum|
|Contact Name:||Dana Atalla|
|Job Published:||about 1 year ago|
Our client a world leading provider of health care technology is seeking a Regulatory Affairs associate for a contract period of 6-12 months. Your role will be to obtain and maintain Marketing Authorisations in territories administered by the regional office. You will be responsible for preparing and submitting marketing authorisations, variation and renewal applications and associated responses to questions, which require submission via the European centralised, decentralised and mutual recognition procedure. You will create regulatory strategies with oversight from mentor/manager. You will contribute to the production of Regulatory Affairs SOP's, job aids and best practices as required. You will assist in the administration of Change Management Procedure including proposing and driving assigned changes. You will guide regulatory activity at a local regulatory team level in alignment with EMEA regional product strategy and provide support in response to requests from regulatory colleagues in the Regulatory Development and On - Market teams as required. You will prepare/check documentation required to support QA release compliant product and manage simple projects and identify risks.
As the ideal candidate you will be able to clearly communicate complex information and ideas in writing and orally in English. You will be proficient at presenting to Regulatory staff, project teams and to regulatory Agencies. You will have the ability to define and execute Regulatory strategies have experience of managing multiple Regulatory projects according to agreed time lines. Good analytical skills with a high attention to details a must. Ability to identify submission risks and suggest mitigation strategies. Effective internal and external communication experience a must.
To find out more kindly email your CV to firstname.lastname@example.org or call Dana Atalla 0n 01202 888986.