Cache of job #14088272

Job Title

Regulatory Officer Compliance

Employer

CPL

Location

DUBLIN WEST

Description

Our client, a global pharmaceutical company, are currently recruiting for a Regulatory Officer – Compliance. This is 24 month contract role. OBJECTIVE. Manage new applications, variations and maintenance of International MA’s. Support New Product Introductions Internationally. Gap analysis and remediation of International CMC documentation. Assist with development of International regulatory strategy and regulatory intelligence. Collaboration with stakeholders to support active MA’s and related activities. Perform assigned tasks right first time, in accordance with best practice and internal processes. Other tasks as requested by Manager. DOSSIER MANAGEMENT Compile and deliver hard copy or eCTD of MA dossiers for requesting country(s. Development of MA dossiers according to local requirements and best practice guidelines. Timely compilation of registration dossier to meet project timelines. Review CMC dossier packages for accuracy, completeness and compliance. Identify and obtain deficient information in order to complete compilation in a timely manner. Due diligence audits of CMC dossiers against current manufacturing procedures and processes. Identification and remediation of risks or deficiencies related to the CMC quality of the dossier. Communication of issues obtaining information necessary for dossier development. Liaise with appropriate stakeholders to resolve issues surrounding successful dossier build. Regulatory advice regarding proposed CMC changes to the registered dossiers. Archive dossier documentation according to internal standards. Update of relevant RA database(s) and associated QA systems. REGISTRATION PROCESS Manage international regulatory submissions according to company strategy and project plans. Timely management of dossier activities in order to support submissions and approvals. Dispatch of documentation to International affiliates. Tracking of CMC packages delivered to affiliates and monitoring final delivery to regulators. Support responses to Health Authorities' queries and deficiencies. Liaise with affiliates and stakeholders in order to maintain, modify and renew product licences. Support New Product Introductions and complete related activities effectively. Build and develop International regulatory strategy and regulatory intelligence. Assist internal and external stakeholders with queries related to product dossier content. Timely communication and escalation of perceived risks, issues and evolving timelines. Requirements. Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree. 1 – 2 year experience in a regulatory affairs environment. Relevant experience in, and general knowledge of, the pharmaceutical industry. Knowledge of EU and other regions current registration and dossier requirements. Knowledge of how to source registration requirement information. Strong computer competency e.g. Word, Excel, Access, Powerpoint etc. Experience with RA and QA pharmaceutical systems. For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671.

Date Added

1569 days ago

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