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Senior Regulatory Affairs Consultant

Woodley BioReg Ltd
Job LocationHuddersfield
EducationNot Mentioned
Salary£30,000 - £50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Do you have a Regulatory qualification and want a competitive salaryThen look no further!(SENIOR) REGULATORY AFFAIRS CONSULTANT£30,000 - £50,000 Dependent on ExperienceHuddersfieldWoodley BioReg Ltd provides high quality consulting services and scientific advice in Regulatory Affairs, Quality, and Project Management for all stages of product development, acting as the link between the global Boards of Health/Regulatory Agencies and healthcare product suppliers and manufacturers.We help pharmaceutical, biopharmaceutical, healthcare and medical device companies develop and manufacture quality products that are effective and safe for patients worldwide.Benefits!

  • Private Healthcare Scheme
  • Life Insurance
  • Company Pension Scheme
  • Company Bonus Scheme
  • Holidays
    • The RoleWe are looking for a someone with a locally recognised professional Regulatory qualification, or working towards, e.g. TOPRA in UK, to be an individual contributor with the purpose of contributing to regulatory and quality project teams and reviewing technical data and providing regulatory review and technical input on our pharmaceuticals and medical devices projects.Key Responsibilities
  • To contribute to regulatory and quality project teams
  • To review technical data as part of a project team
  • To provide regulatory review and technical input
  • To provide quality review and input
  • To become point of contact on medical devices information
  • To learn and develop skills in order to prepare and contribute to regulatory documentation (e.g., relevant sections within CTAs, MAAs, INDs and NDAs, Variations, Renewals, Technical Files, CE Marking), etc.
  • Regulatory documentation preparation (e.g. relevant sections within CTAs, MAAs, INDs, NDAs, CE marking, 510K)
  • To comply with Woodley BioReg and clients’ Quality Standards
  • To continuously develop technical, interpersonal skills
  • To engage with the wider team and sector to gain wider knowledge of the industry, changes in legislation and working procedures affecting the environment of Woodley BioReg
  • Provide support to other functions with Woodley BioReg as requested
  • To build and maintain expertise and develop a scientific profile in appropriate scientific disciplines, through publication and attendance at relevant scientific and regulatory meetings and/or conferences
  • Ad hoc activities / project work as required
    • Skills and Qualifications
  • BSc, or country equivalent, as a minimum, in a relevant life-science subject
  • Life science graduate or equivalent
  • 0-8 years regulatory experience
  • Experience of medical devices industry e.g. at least an undergraduate placement year
  • Experience of the pharmaceutical industry
  • Excellent organisational skills, attention to detail, interpersonal and communication skills (written and oral) are essential
  • Professionalism, being able to adapt to client situations and manage and deliver client expectations.
  • Quality, to deliver work which is of a high standard
  • Productivity, be able to focus on delivery to achieve project objectives
  • Accuracy, ability to utilise technical ability and ensure attention to detail
  • Value adding activity
    • Special Factors
  • Overtime and weekend work as required
  • Ability to attend domestic and international technical conferences/exhibits, as required
  • In order to fulfil the role of a Regulatory Consultant, the jobholder must develop an up to date knowledge of developing regulatory / registration requirements within the UK and EU
    • Travel Requirements
  • Role is primarily office based
  • Travel as required: approximately 5 - 10% of time
  • Travel is primarily: UK & Europe
  • Global Travel may be required
    • How to apply for the (Senior) Regulatory Affairs Consultant job - No AgenciesIf you have the skills and experience required for this (Senior) Regulatory Affairs Consultant job, just click "apply" today and watch out for an email giving you more information on how to tailor your application and provide a cover letter or any other supporting documents you may have.You must be eligible to work in the UKSuitable skills and experience include: (Senior) Regulatory Affairs Consultant, Pharmaceuticals, Regulatory Consultant, Medical Devices, TOPRA, Life-Science, Medical Manufacturing, Healthcare

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