Regulatory Affairs Specialist - Permanent job - Galway

The successful candidate will prepare and submit medical regulatory dossiers, support and coordinate with customers, inter and intra departmental colleagues and medical Business development managers.

RESPONSIBILITIES:

• Compilation of regulatory dossiers for EU National and MRP/DCP Marketing Authorisation (MA) applications
• Responding to queries raised by the regulatory authorities / customers
• Maintaining regulatory information on database
• Artwork review and approval
• High level review of process validation protocols and reports for inclusion in Module 3.
• High level review of assay validation data and stability data to be included in Module 3
• Transfer of data from Regulatory Department to other departments & external partners
• Working with Qualified Persons Responsible for Pharmacovigilance (QPPV’s) in line with EU & In-house pharmacovigilance procedures and practices.
• Supporting other departments and external partners

CRITERIA FOR ROLE:

• Good communication skills (written and orally), with the ability to work in a busy environment and on multiple projects simultaneously to tight deadlines.
• Scientific qualification and background, preferably B.Sc or equivalent.
• Prior experience in regulatory/R&D/Quality environment, preferably with experience in generic applications.
• Good technical knowledge, good attention to detail and good IT skills in word and excel are essential.
• Strong Customer Service focus is key to this role

Interested candidates please contact Annette Murphy on 091 507515 or email your CV in confidence to annette.murphy@cpl.ie