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Job Title: Senior Regulatory Affairs Associate
Contract Type: Contract
Location: Berkshire, Berkshire
Industry:
Salary: £45000.00 per annum
Duration: 6-12 months
REF: HQ00018965
Contact Name: Dana Atalla
Contact Email: datalla@allen-york.com
Job Published: 12 months ago

Our Client a World leading provider of Health care technology is seeking a Senior Regulatory Affairs Associate on a temporary basis for their UK operation. Your role will be to obtain and maintain Marketing Authorisations in territories administered by the UK regional office. You will prepare and submit (according to required time lines), 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 review colleagues submissions as required. You will be responsible for the creation of regulatory strategies that identify risks/benefits associated with the submission. You will contribute to the production of Regulatory Affairs SOP's, job aids and best practices as required, assist in the administration of Change Management Procedure including proposing and driving assigned changes. You will determine the EMEA regional product strategy and guide to regulatory activity at a local regulatory team level in alignment with Regional 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 products, proficiently manage multiple projects, identifying and managing submission risks in conjunction with the project team and offices. You will also deputise for the RPO Manager on project related activity as required.

As the ideal candidate you will possess at least 2-3 years FMCG or Pharmaceutical Regulatory affairs experience in a similar environment and too have managed and executed multiple projects at a time.

To find out more kindly email your CV to datalla@allen-york.com or call Dana Atalla 0n 01202 888986.

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