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Regulatory Affairs Consultant

Real Staffing
Job LocationGlasgow
EducationNot Mentioned
Salary65,000 - 75,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client is a boutique regulatory consultancy working with household names and start-ups in the life science sector providing a variety of regulatory services. This is a unique opportunity to join a business which is employee owned and share in the futuresuccess of the organisation.The Regulatory Consultant will be an active member of the Regulatory Affairs team and works alongside the Senior Management Team and Consultants in supporting the regulatory and document writing activities.Responsibilities:

  • Support and lead regulatory projects, which may involve strategy, scientific advice or procedures relating to marketing authorisations.
  • Preparation of documents to support regulatory activities at various stages of pharmaceutical or medical device development, including:
    • Clinical Summaries and Overviews based on study and/or literature information
    • Risk Management Plans
    • Responses to Agency Requests
    • Other regulatory documents such as Scientific Advice briefing documents, PIPs, Orphan Designations
    • SmPCs and package leaflet
    • Investigators Brochures
    • Clinical Evaluation Reports
    • Educational materials for HCPs/clients, including training materials, slides, posters and presentations for conferences
  • Ensuring that the content, format and structure of their documents comply with regulatory, journal, or other guidelines
  • Support activities of more junior regulatory and administration staff on specific projects
  • Liaising with clients in collation, review and delivery of regulatory documentation
  • Explore and develop new work opportunities for the business
  • Develop and implement initiatives to train and strengthen the regulatory knowledge of the Team.
Skills:
  • Communication in various written formats and face to face
  • Regulatory and medical writing
  • Ability to present complex information in a logical way
  • Attention to detail
  • Project-management mentality and a proven ability to meet deadlines
To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales

Keyskills :
Medical WritingPharmaceuticalRegulatory AffairsBiotechMedical Device

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