Associate Regulatory Affairs

Job Ref: J32051
Sector: Science
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 24 May 2019
  • Dún Laoghaire, Dublin, Republic of Ireland, Ireland Dún Laoghaire Dublin Ireland t12
  • Competitive
    HOUR
  • Camila Lanzillo
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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Regulatory Affairs Associate - 12 months contract - Dublin

SRG are a strategic recruitment partner to a global pharmaceutical company who are looking for Regulatory Affairs Associate to join the team in Dublin.

The role:

  • Registration document(s) procurement, preparation, coordination submission and archival
  • Coordinates legalization and delivery of registration documents following the instructions provided in the request.
  • Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
  • Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
  • Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.

Requirements:

  • Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
  • The applicant should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
  • Proficient use of MS Office tools, SharePoint and strong computer aptitude.
  • Solid working knowledge on document management systems such as Documentum.

  • Preferred:

Bachelor's degree or higher in Regulatory, Life Sciences, Biotechnology or related discipline. A minimum of 4 years of related pharmaceutical industry experience.

To apply for this position, please apply online or email a copy of your CV camila.lanzillo @srg.co.uk

#RA #pharma # pharmaceutical #science #CMC #Regulatory #GMP

SRG
23/06/2019 11:39:46
EUR