• Cork

Initial 18-month contract role. Hybrid role (3 days on site, 2 remote).

 Position Summary:

This position is responsible for supporting tasks and projects related to management of Regulatory Compliance and new product submissions. These activities include QA/Compliance support for worldwide submissions of new drug applications and post approval changes, change control support, manufacturing support and manufacturing license maintenance.

  • Point of Contact to request, source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, Deviations, Quality Agreements) to support miscellaneous regulatory requests such as paper-based inspections (e.g. Taiwan, Japan etc).
  • In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses
  • Notarization and legalization management.
  • In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests.
  • Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the company sections are accurate and consistent across all products.
  • Works with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows.
  • In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required.
  • Familiarization with license content and license sections in eCTD viewer and work with both the QPs and Regulatory Manager to ensure transparency of information and escalation information is shared.
  • Regulatory support for routine manufacturing / Quality operations.

Required education and experience

  • Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc is required.
  • Minimum of level 8 qualification in a science/regulatory compliance or a relevant field.
  • Minimum of 2~3yrs previous QA experience within pharma.
  • Regulatory compliance experience is a requirement for this role.

Maximum file size: 2MB