Regulatory Compliance Specialist (18m, Cork)

CareerWise Recruitment

Cork

REGULATORY COMPLIANCE SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in Cork, 18 month contract on offer and this is a hybrid (3 days onsite) role. The REGULATORY COMPLIANCE SPECIALIST will join a team of 3- 4 QA Specialists working primarily on reg compliance activities, the team supports the registration and approval process for new products being submitted to the various health authorities. THE ROLE: * 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 (e.g. Taiwan, Japan etc. * 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. REQUIREMENTS: * Degree qualified in relevant scientific discipline. * Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc. Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@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.

580 days ago