Cache of job #14120173

Job Title

Regulatory Affairs Specialist

Employer

CAREERWISE RECRUITMENT

Location

WATERFORD

Description

Regulatory Affairs Specialist is required by CareerWise Recruitment for our County Waterford based client. THE ROLE: * Assist in the development of regulatory strategies. * Determine and communicate submission and approval requirements. * Assess the acceptability of documentation for submission. * Coordinate and prepare submission packages for regulatory agencies. Monitor the content of the dossiers ensuring the content is consistent, understandable and the results clearly expressed and that open questions have been dealt with. * Respond to questions raised by regulatory authorities by obtaining the relevant information from departments concerned. * Negotiate with regulatory authorities to achieve most favourable conditions for marketing authorisations or variations. * Commission and approve artwork for compliance prior to final signoff. * Draft Summary of Product Characteristics, Patient Information Leaflets and packaging. REQUIREMENTS: * Educated to at least degree level in a life science with significant experience in regulatory affairs. * Membership of The Organization for Professionals in Regulatory Affairs (TOPRA) is preferable. * Ability to organise own workload with a minimum of supervision. * He/she should have a basic appreciation of all aspects of the working of the pharmaceutical industry. * Experience with information technology desirable. Please call Mike Morrissey today for further information on 021-429 7536 or email: mmorrissey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Date Added

1365 days ago

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