Overview

Reference Number: JO-2107-471744
Senior Regulatory Operations Associate
Rate: Negotiable
Job Type: Permanent
Location: Dublin City Centre

Senior Regulatory Operations Associate

Location: Ireland, Dublin

Permanent position

Salary: Highly competitive salary & package, including long-term incentives.

Job reference:JO-2107-471744

CPL Life Sciences are collaborating with a global pharmaceutical to hire a Senior Regulatory Operations Associate. In this position youll oversee all regulatory publishing activities, ensuring theyre at the highest quality as well as overseeing the effective and appropriate management for regulatory documentation. Other duties include.

-Publish and validate complex submissions including documents for EU Paediatric submissions

-Provide oversight for the selection and management of any outsourced publishing and records management vendors

-Develop proposals for continuous improvement of internal systems and processes

-Leads projects of high complexity, making independent and appropriate decisions.

-Lead cross-functional projects and represent Reg Ops at project meetings

Requirements

-5+ years experience working within a Regulatory Operations position

-Ability to direct operational staff to achieve submission publishing timelines

-Experience working within pediatrics highly advantageous

-Expertise with submission publishing tools (eCTD building tools

-Experience with publishing, validating, and submitting full marketing applications in eCTD format for EU

If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or Charlie.harris@Cpl.com

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