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Regulatory Affairs Senior Manager

Haybury Limited
Job LocationUxbridge
EducationNot Mentioned
Salary£61.00 - £62.00 per hour
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 oncology product development and implementation of regional regulatory strategies in clinical trials.Within this role you will:

  • Utilise your expertise to ensure the maintenance of licenses required to support clinical trials are maintained
  • Work within an innovative 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
  • Deliver guidance for regional regulatory strategy and support of labelling through the use of strategy and management of agency collaborations
  • Administration of core Regulatory activities
    • You will bring to the role:
  • A degree in a Science related discipline
  • Demonstrated knowledge of Regulatory principles supporting clinical trials, particularly in the early phase
  • Thorough knowledge and background working within Regulatory Affairs environment, in the Oncology therapy area or with knowledge of the differences in Regulation regarding oncology, with proven experience working with SOPs and Regulation relating to medicinal products
  • Sensitivity and consciousness of cultural systems, to achieve results across international borders and regional country
  • Strong familiarity with strategy from an EU perspective, alongside experience with orphan drug applications or preparations with pediatric planning
  • Comprehensive knowledge of full lifecycle drug development
  • Wholesome understanding of regulatory procedures in region EU for MAs, CTAs, post-approval changes and amendments, extensions and renewals
    • In return you will receive:
  • A role in a leading biotech company
  • The ability to work in an energetic, motivated team
  • A competitive salary
  • Identification and reward for outstanding accomplishments
  • The ability to develop within a supportive and development orientated organisation
    • If you have the skills and experience for this opportunity and the ambition to take on this position, please email your CV today.Alouette is a Search Consultant at Haybury Search covering Europe, UK, North America and Asia

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