Vet Regulatory Affairs Executive

CPL

Galway

Vet Regulatory Affairs Executive. Job Responsibilities: Compilation of CTD regulatory dossiers Module 1 – 5 for EU National and MRP Marketing Authorisation (MA) applications. Review of process validation protocols and reports for inclusion in Module 3. Review of assay validation data and stability data to be included in Module 3. Review of Drug Master Files. Review of protocols for Bioequivalence studies and Biostudy reports. Auditing CRO’s, monitoring of biostudies. Writing of Quality Overall Summaries for European MA’s. Responding to queries raised by the regulatory authorities. Preparation and submission of renewal applications for existing MA’s. Preparation and submission of variation applications to existing MA’s. Artwork review and approval. Transfer of data from Regulatory Dept to QA and Production. Timely and accurate preparation of CTD dossiers. Timely and accurate preparation of responses to authority questions. Working with Qualified Persons Responsible for Pharmacovigilance (QPPV’s) in line with in-house pharmacovigilance procedures and practices. Attention to detail in generation of dossiers, protocols and reports. Ability to work on multiple projects simultaneously. Communication skills with external and internal customers. Job Requirements: Scientific qualification and background preferably BSc or equivalent. Minimum 3-5 years in a regulatory/R&D environment preferably with experience in MRP and generic applications. Experience in busy problem solving environment with the ability to work to tight deadlines and on own initiative. Good communication skills both written and orally. Detailed technical knowledge of products and processes. Good IT skills and computer literate preferably to ECDL level. Strong Customer Service focus both internally and externally. For more information regarding this role contact Brenda Flannery on 091 507 521 or email Brenda.flannery@cpl.ie. Visit www.cpljobs.ie for more of our open roles. This job originally appeared on RecruitIreland.com.

1721 days ago