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Regulatory Affairs Senior Manager

Haybury Limited
Job LocationUxbridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Our client is a prominent patient driven global biotech organisation who are looking for an experienced Regulatory Affairs professional to work on an initial 12-month contract. You will utilise your Regulatory expertise to provide support for medicinal product development and implementation of regional regulatory strategies in clinical trials.Within this role you will:

  • Deliver guidance for Regional Regulatory strategy and support of labelling through use of strategy and management of agency collaborations
  • Utilise your expertise to ensure maintenance of licenses required to support clinical trials are maintained
  • Work within a ground-breaking Global Regulatory Team, supporting and leading timely regulatory compliance for approvals
  • Take responsibility for and manage regional regulatory leads and support staff
  • Provide management for Regulatory employees
  • Administration of core Regulatory activities
    • You will bring to the role:
  • Strong familiarity providing strategic input from an EU perspective for clinical trials,
  • Demonstrated knowledge of Regulatory principles, alongside experience with orphan drug applications, preparations for PIP’s particularly in early phase and registration strategies
  • Solid familiarity and proficiency in a Regional Regulatory setting
  • Thorough knowledge Comprehensive knowledge of full lifecycle drug management activities for medicinal products alongside familiarity with SOP’s
  • Experience leading Health Authority interactions with EMA
  • Extensive understanding of regulatory procedures in region EU for MAs, CTAs, post approval changes
  • Capabilities with scientific and technical drug development
    • In return you will receive:
  • A role in a prominent biotech company
  • The ability to work in an active, motivated team
  • A competitive salary
  • Identification and reward for exceptional accomplishments
  • The ability to grow within a compassionate and development orientated organisation
    • If you have the skills and experience for this opportunity and the ambition to take on this position, please call Alouette for further details or email your CV today.Alouette is a Search Consultant at Haybury Search covering Europe, UK, North America and Asia

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