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Clinical Regulatory Affairs Associate - B

Abbott Park, ILRandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/296042
 

Job Title:  Clinical Trials Contractor, Clinical Trial Regulatory Group


Position Description

  • Provide comprehensive strategic and operational support to ensure regulatory approval and compliance for clinical trials conducted worldwide ex USA & Canada
  • Support Regulatory Affairs Area and Affiliate colleagues responsible for development compounds with strategic and operational advice for clinical trials.

Position Responsibilities

 

Clinical Trial Subject Matter Expert

  • Provide advice on submission strategy (e.g. VHP vs. National), contribution to substantial & non-substantial decisions for amendments, safety reporting processes, distribution and supply issues, GCP & safety issues and country specific requirements.
  • Serve on CTA submission team meetings as area and affiliate strategy regulatory representative
  • Provide ad hoc support for CTA related projects throughout the organisation.

Operational Support

  • Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities; substantial amendments, end of trials notifications etc.
  • Preparation of cover letters, Annexes 1, 2 and 3, liaison with VHP-coordinator
  • Liaise with key contacts in Regulatory Affairs, Clinical Study Management, Clinical Operations, Supply Chain and local affiliates to identify & resolve issues
  • Input into CA & EC response to questions/requests for information
  • Support inspection readiness activities when applicable

Project Management, Process Compliance and Communication

  • Ensure approved company CTA processes are followed within agreed timelines
  • Undertake all necessary training in order to achieve compliance with internal/external processes
  • Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met
  • Monitor key project milestones, communicate changes to assigned stakeholders and management as agreed in company procedures
  • Participate in process improvement initiatives
  • Support SOP reviews and updates as required

Key internal and external interfaces

  • Area & Affiliate Regulatory Product Leads
  • Global Regulatory Leads
  • Global Clinical Study Management, Clinical Field Operations
  • Global Chemistry, Manufacturing & Controls
  • Global Distribution and Supply Management
  • Clinical Research Organisations (CROs as appropriate)
  • Quality Assurance
  • Local affiliate offices

Position Requirements

  • Life Sciences Degree or similar with relevant experience.
  • Has a minimum of two years’ experience in EU clinical trials authorization applications and associated regulatory CTA activities in the pharmaceutical industry or CRO.
  • Is able to plan, set-up and execute all elements required to obtain regulatory approval of a clinical study within EU and rest of world countries (ex US)
  • Excellent understanding of the EU Clinical Trials Directive and associated guidelines, Good Manufacturing Practices and Good Clinical Practices, ICH and other pertinent guidelines as they relate to the manufacture and release of clinical trial supplies to the investigator.
  • Experience of Voluntary Harmonisation Procedure is preferable
  • Has successful experience working in a matrix/cross-functional environment.
  • Is able to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites
  • Has excellent communication/presentation skills, written and verbal; fluency in English.
  • Shows high level of initiative and ability to work independently.
  • Has critical reasoning skills including the identification and resolution of complex problems and/or elevation of issues to relevant line functions and management.
  • Strong Project Management skills, able to manage multiple activities in line with business priorities and study time goals

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/296042