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Junior Regulatory Affairs Pharma/Med Device

Russell Taylor Associates
Job LocationManchester
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Role: - Junior Regulatory AffairsSalary: - CompetitiveLocation: - ManchesterRussell-Taylor Group have a fantastic opportunity for a junior regulatory affairs associate/officer to join a rapidly expanding pharmaceutical manufacturer/distributor in the North West. If you have 1-2 years RA experience in a pharmaceutical environment, then please apply within.Responsibilities

  • Support the Head of Regulatory services for existing product portfolio and future product opportunities for medicinal products and medical devices- submissions and retrieval of analytical/manufacturing process data to support MAA
  • Assist the PV team when required in relation to medical information queries, upload of approved product information to the eMC & ensure that additional risk minimisation measures required for a product are implemented (e.g.- additional follow up)
  • Support audit preparation activities for department and of external vendors
  • Assist in performing gap analysis
  • Validate that product packaging is updated and maintained in accordance with product licences & international territories which may include the review of artwork for product packaging.
  • Involvement in regulatory team meetings and manage assigned tasks with regular updates to the team
  • Ensure that planning, preparing, tracking, and storing submissions to regulatory agencies are regularly updated and used.
  • Maintenance of new & existing Marketing Authorisations registered via National and potential Material requirement planning.
  • Communicate efficiently with key stakeholders both internally and externally- building a good relationship with them!
  • Ensure familiarity with the companys product range and keep up to date with the companys regulatory standards and legislation for both UK and EU. As well as ensuring quality standards are consistently met and submissions are made accordingly.
  • For both national and mutual recognition procedures prepare, compile, and submit a range of regulatory applications
  • Liaise with various departments including Company Engineers and the Procurement Team to create, maintain and implement approved artwork drafts
  • Report to the QPPV any updates on regulatory applications
  • Liaise with the finance department with arrange payment fees to MHRA and other authorities when required
  • Review and update SOPS to ensure they comply with applicable legislation with the UK & EU
  • Actively seek to minimize risks to the business, Manage and alert risks via the Regulatory and Quality Manager
    • The Person
  • BSc in a life science, healthcare, or pharmaceutical discipline
  • Knowledge of national and MRP in the UK/EU
  • Experience within RA within either Pharmaceutical or Medical Device
  • Excellent understanding of analytical & manufacturing sciences in the pharma industry
  • Experience or preparing and submitting post-marketing regulatory applications to the MHRA (variations, renewals, post-marketing commitment submissions, PSURs)
  • Experience of writing and updated product information documents to an excellent standard. This will include development of labelling & leaflet artworks.
    • Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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