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Regulatory Affairs Manager

Marketplace Group
Job LocationLondon
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

UK based Pharmaceutical Manufacturer and R&D Laboratory seeks a Regulatory Affairs Manager.About the role:

  • To work with colleagues in process development, production, quality, project management, pre-clinical and clinical (functions represented both within and via external consultants and CROs), to compile IMPDs, clinical trial applications, INDs, DMFs etc. and to maintain a regulatory correspondence file.
  • To support the product development team, working with the Head of Quality, in interpreting the regulatory requirements of early clinical development and work with them to ensure data and reports meet the necessary standards of external agencies.
  • To take externally facing responsibility to regulatory agencies, including point of contact, requesting and chairing meetings.
    • Skills and experience:
  • A minimum of 4 years-experience working in a regulatory affairs environment, in early clinical development. Since the company work with a highly specialised manufacturing technology, experience in compiling IMPDs and working with manufacturing professionals is essential.
  • A highly self-motivated, flexible and quick-thinking attitude to meeting the needs of the rapidly evolving state-of-the-art field.
  • Excellent interpersonal skills are needed to bring cross functional teams together for a common goal.
  • Experience of regulatory interactions (FDA/EMA/MHRA) related to product/clinical development is essential.
  • A working knowledge of all stages of clinical development of biopharmaceuticals and small molecule drugs is required.
  • Credibility and authority to represent the company is essential.
  • Excellent organisational, project management, budgeting and problem-solving skills would be welcomed.
  • Applicants MUST be eligible to work in the UK.
    • Required skills
  • GMP
  • Manufacturing
  • Regulatory Affairs

    • Keyskills :
    GMP Manufacturing Regulaty Affairs

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