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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Assessor, National Licensing (Acting)


Reference:SCA015874 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Pharmacist

Assessor, National Licensing (Acting)
Our client, a large regulatory body, are currently recruiting for an Assessor of National Licensing to join their team. As the Assessor, you will evaluate the quality and clinical aspects of new applications, variations, and renewals for human medicinal products. The role involves working closely with cross-functional teams and key regulatory stakeholders to support national and EU licensing operations. This role offers hybrid working with two days in the office and three days working from home.

Responsibilites:

  • Technical Evaluation: Conduct scientific assessments of quality, safety, and clinical data for marketing authorisations, variations, renewals, bioequivalence, and generic applications.
  • Risk-Benefit Analysis: Evaluate benefit-risk profiles in a public health context and present recommendations to advisory boards and committees (including CHMP/EU working groups).
  • Operational & QMS Support: Support section goals, organize efficient workflows, maintain Quality Management System (QMS) procedures, and ensure accurate data input in regulatory databases.
  • Stakeholder Engagement: Provide expert technical guidance and liaison to applicants, healthcare professionals, state bodies, and regulatory authorities.
Requirements:
Essential:
  • Education: Degree in Pharmacy, Chemistry, or a relevant scientific discipline.
  • Experience: Minimum 2 years of relevant industrial, regulatory, or research experience in the pharmaceutical sector.
  • Key Skills: Strong multidisciplinary teamwork, communication, problem-solving, and stakeholder management skills.
Desirable:
  • Postgraduate qualification in a relevant discipline.
  • Experience reviewing quality dossiers for marketing authorisations.
  • Experience interacting with European regulatory frameworks or agencies.
For more information please contact Sinéad Cullen on +353879500821 or [email protected]