Cache of job #14120221

Job Title

Senior Regulatory Affairs Officer

Employer

CPL

Location

DUBLIN SOUTH

Description

On behalf of our client, a small pharmaceutical company, we are currently recruiting for a Senior Regulatory Affairs Officer. This will initially be for a 12 month contract. There is good flexibility to be partially home based. The role reports to the Associate Director of Regulatory Affairs. Regulatory. Review current registration dossier for all marketed products to identify and record dossier completeness, formatting issues, compliance with guidelines / legislation, on-going regulatory issues (pending variations) and outstanding regulatory commitments. Ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU and international standards. Managing and coordinating various regulatory activities throughout the life cycle of the project / product. Maintain assigned products’ Marketing Authorisations via timely variations and renewals submissions and their approvals. Ensure meeting registration timelines, via timely response to queries from Health Authorities’ and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, where required. To contact and liaise directly with Regulatory Agencies as required. Provide project-specific Regulatory Strategic advice, technical expertise and coordination oversight for assigned projects. Direct / mentor other RA individuals assigned to support projects of responsibility, as appropriate. Participate in project launch meetings, review meetings and project team meetings as required. Share up-to-date legislation and guidance with RA colleagues as appropriate. Build departmental awareness of local regulatory requirements in EU and international markets and provide regulatory advice, guidance and support to all project teams, as required. Support compilation of regulatory component of annual product quality reviews. Maintain regulatory files / databases in chronological order. Establish and maintain system for tracking changes in documents submitted to agencies or partners. Archive the registration documentation according to internal processes; introduce regular updates to internal RA database(s. Appropriate planning for prioritization and coordination of activities among functional areas and within Regulatory Affairs, and for timely identification and communication of project/product related concerns to the relevant departments such that same can be addressed in a timely manner. Other. Assisting in the effective implementation of the company’s Quality Management System within the Compliance department. Regulatory assessment on all change controls and other documentation, ie. stability protocols, specifications, product quality reviews and related reports to ensure compliance with current registered dossiers and commitments made to agencies. To inform, advise and maintain current awareness of regulatory licence requirements. To develop and maintain systems and procedures to ensure efficient processes and best practice. Good understanding of GMP and GDP. Education & Experience. Bachelor’s Degree in Pharmaceutical discipline with 5+ years of experience in quality and regulatory teams within cosmetic and pharmaceutical manufacturing facilities. Knowledge, Skills and Abilities. Attention to detail and quality of documentation. Good interpersonal skills. Familiar with computers and their applications, eg. Word, Excel, Power Point. Effective oral and written communication skills in English language as well as local language where applicable. Basic organizational and planning skills. Good negotiation skills. Ability to work independently with direction. Proven ability to work effectively in a team environment. Ability to handle multiple projects. Analytical and investigative skills. Ability to interpret data. Good judgement and decision-making skills. Ability to act as liaison with other departments. For a full Job Spec 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. www.thornshaw.com Tel: +353 1 2784671.

Date Added

1365 days ago

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