Cache of job #14101938

Job Title

Regulatory Compliance Specialist (12m)

Employer

CAREERWISE RECRUITMENT

Location

CORK

Description

REGULATORY COMPLIANCE SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in Cork, initial 12 month contract on offer. The REGULATORY COMPLIANCE SPECIALIST is the point of contact to request, source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, Deviations, Quality Agreements) to support miscellaneous regulatory requests such as paper-based inspections. THE ROLE: * In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses. * Notarization and legalization management. * In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests. * Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the sections are accurate and consistent across all products. * Works with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows. * In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required. * Familiarization with license content and license sections in eCTD viewer and work with both the QPs and Regulatory Manager to ensure transparency of information and escalation information is shared. * Regulatory support for routine manufacturing / Quality operations. * Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc. REQUIREMENTS: * Degree qualified in a science discipline. * At least 4 years in a QA role in a pharmaceurtical environment. * Collaboration and team work. * Problem solving and attention to detail. * Customer focused. * Clear communication skills. * Adaptable and flexible.

Date Added

1502 days ago

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