Regulatory Officer Compliance

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Job Description

Our client, a global pharmaceutical company, are currently recruiting for a Regulatory Officer – Compliance. This is 24 month contract role.

OBJECTIVE

  • Manage new applications, variations and maintenance of International MA’s
  • Support New Product Introductions Internationally
  • Gap analysis and remediation of International CMC documentation
  • Assist with development of International regulatory strategy and regulatory intelligence
  • Collaboration with stakeholders to support active MA’s and related activities
  • Perform assigned tasks right first time, in accordance with best practice and internal processes
  • Other tasks as requested by Manager

 DOSSIER MANAGEMENT

  • Compile and deliver hard copy or eCTD of MA dossiers for requesting country(s)
  • Development of MA dossiers according to local requirements and best practice guidelines
  • Timely compilation of registration dossier to meet project timelines
  • Review CMC dossier packages for accuracy, completeness and compliance
  • Identify and obtain deficient information in order to complete compilation in a timely manner
  • Due diligence audits of CMC dossiers against current manufacturing procedures and processes
  • Identification and remediation of risks or deficiencies related to the CMC quality of the dossier
  • Communication of issues obtaining information necessary for dossier development
  • Liaise with appropriate stakeholders to resolve issues surrounding successful dossier build
  • Regulatory advice regarding proposed CMC changes to the registered dossiers
  • Archive dossier documentation according to internal standards
  • Update of relevant RA database(s) and associated QA systems

 REGISTRATION PROCESS

  • Manage international regulatory submissions according to company strategy and project plans
  • Timely management of dossier activities in order to support submissions and approvals
  • Dispatch of documentation to International affiliates
  • Tracking of CMC packages delivered to affiliates and monitoring final delivery to regulators
  • Support responses to Health Authorities' queries and deficiencies
  • Liaise with affiliates and stakeholders in order to maintain, modify and renew product licences
  • Support New Product Introductions and complete related activities effectively
  • Build and develop International regulatory strategy and regulatory intelligence
  • Assist internal and external stakeholders with queries related to product dossier content
  • Timely communication and escalation of perceived risks, issues and evolving timelines

Requirements

  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • 1 – 2 year experience in a regulatory affairs environment
  • Relevant experience in, and general knowledge of, the pharmaceutical industry
  • Knowledge of EU and other regions current registration and dossier requirements
  • Knowledge of how to source registration requirement information
  • Strong computer competency e.g. Word, Excel, Access, Powerpoint etc
  • Experience with RA and QA pharmaceutical systems

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.  Tel: +353 1 2784671

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Linda Dunne

Senior Recruitment Consultant ldunne@thornshaw.com
  • Salary:Negotiable
  • Location:Dublin South
  • Type:Contract
  • Category:Science,Thornshaw
  • Ref.no:JO-1912-442155_11