Company: Thornshaw Recruitment
Closing Date: 18 Nov 16
Salary (£): On Application
Our client a global pharmaceutical company now have a requirement for a Regulatory Affairs Officer with experience in medical devices.
Our client a global pharmaceutical company now have a requirement for a Regulatory Affairs Officer with experience in medical devices. Permanent role based in Dublin.
• Ensure timely preparation and compilation of registration dossier components in accordance to EU or relevant Health Authority standards, and corporate requirements
• Under supervision of the senior RA person (if required), manage international regulatory submissions according to company strategy and ensure registration deadlines are met
• Responding to Health Authorities' queries and deficiencies in a timely manner
• Liaise with other departments to support the timely introduction of new product into markets
• Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner
• Communication of Health Authority approvals/final decisions to the relevant departments
• Build departmental awareness of local regulatory requirements in global markets
• Compile regulatory components of annual product quality review (PQR)and PSUR/PBER
• Archive the registration documentation according to internal standards; introduce and regularly update internal RA databases
Perform assigned tasks with the highest quality and in accordance with established internal timelines and guidelines
• Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
• Experience in a regulatory affairs environment required
• Experience in the Medical Device/pharmaceutical industry
• Working knowledge of current registration requirements for dossier preparation and procedure running an advantage
• Solid knowledge of specific national requirements in usual target registration countries an advantage
• IT tools utilised in RA department e.g. for Regulatory intelligence, eCTD, change control etc.
For full details contact Tina at +353 12784671 or email your CV to email@example.com - For all vacancies log on to www.thornshaw.com
Barton House 6 Old Dublin Road Stillorgan Co. Dublin
|Tel:||00 353 (1) 278 4671|
|Fax:||00 353 (1) 278 4672|
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