Group 10
Responsibilities

In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more!

  • Compile, or supervise the compilation of regulatory dossiers
  • Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
  • Provide regulatory support to clients and associate companies
  • Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
  • Review tasks for, support and mentor Regulatory Affairs Associates

Group 13
Profile

  • UK and IE lifecycle maintenance experience
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Assisting with license applications as required.
  • Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II, BSVs, Renewals, PIQ, BROMI and MAH Transfers/COAs
  • Preparation and submission of Technical/Site Transfer Applications
  • Assisting with the preparation of UK and IE Marketing Authorisation Applications
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
  • Ensuring compliance with the regulations of the MHRA and HPRA
  • Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), LorenZ, Trackwise etc
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
  • General regulatory administration duties and compliance requirements

Group 13

  • Experience of promotional/non-promotional activities would be an advantage
  • Experience of operating within the post-Brexit regulatory landscape in UK and IE
  • Good IT skills/knowledge
  • Good organisational skills
  • Good communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritise different workloads/multi-task

Personal responsibility for ensuring a high standard of work

Regulatory Affairs Officer 633