Cache of job #14157716

Job Title

Regulatory Compliance Specialist (12m, Cork)

Employer

CareerWise Recruitment

Location

Cork

Description

REGULATORY COMPLIANCE SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in Co. Cork, initial 12 month contract on offer. The REGULATORY COMPLIANCE SPECIALIST is responsible for executing regulatory and compliance related tasks and project activities supporting both the Quality Assurance and Regulatory Affairs departments. THE ROLE: * Maintenance of the Clinical and Commercial Health Products Regulatory Authority (HPRA) Manufacturing Licenses by preparing and submitting application updates in a timely manner. * Collaborate effectively with Notary Public on the management of notarisation and legalisation requests. Ensure availability of related PO's and appropriate logging and tracking of requests. * Assist and co-ordinate with Regulatory Management on Country Specific Requests (CSRs) for initial registrations and renewals. * Co-ordinate paper-based inspections for product renewals and new submissions as per Health Authority timelines. REQUIREMENTS: * Bachelors Degree in a scientific/technical discipline required. * A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. * Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities. * Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. * Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. 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.

Date Added

674 days ago

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