ProductLife Group is seeking a Regulatory Affairs Officer/Specialist with UK, IE experience to join our dynamic team and support our Hub activities.

Specific activities and responsibilities:

UK, IE and XI regulatory knowledge is mandatory

 

Required education:

Degree in relevant life science discipline, RA

Required experience :

2-3 years of regulatory affairs experience with UK, IE and XI regulations.

Required technical skills:

  • Lifecycle maintenance experience with UK, IE and XI market
  • Responding to internal requests for technical and/or regulatory information
  • Regulatory intelligence support for UK, IE and XI market
  • Providing support during external and unannounced audits
  • Assisting with license applications as required
  • Assisting with aRMM (educational material) activities
  • 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, IE and XI Marketing Authorization 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
  • Experience in use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data e.g. 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
  • Management of artwork generation
  • 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 organizational skills
  • Good communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work

Regulatory Affairs Officer / Specialist 259