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Regulatory Affairs Specialist

PE Global
Job LocationMaidenhead
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Regulatory Affairs Specialist required for a 6-month contract role with a leading multinational client based in Maidenhead - Remote work within UK.Responsibilities

  • Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
  • Supports the Northern Europe Cluster team (as appropriate) for UK, Ireland & Malta across the Consumer Health portfolio range.
  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
  • Responsible for regulatory activities related to National and/or European procedures (Decentralised, Mutual Recognition) as appropriate..
  • Define regulatory strategies (local and regional) in line with business plan.
  • Prepares and compiles regulatory submissions (Marketing Authorisations Applications, Renewals Variations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU & UK regulations and guidelines.
  • Sign off packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions.
  • Global, EAME and local databases are fully maintained.
  • Processes, SOPs, working instructions and Job Aids are adhered to.
  • Supports the Northern Europe Regulatory team by assisting in any Pharmacovigilance related activities.
    • Requirements
  • Life sciences or chemistry graduate to honours level or equivalent.
  • Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience.
  • Must have hands on experience in management of day-to-day UK and EU regulatory procedures
  • Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential.
  • Project management experience.
  • Understanding of regulatory environment and interaction with the Regulatory Authorities (as appropriate).
    • Interested candidates should submit an updated CVPlease click the link below to apply, call Alba on + or alternatively send an up to date CV***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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