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Job Details

Regulatory Affairs Executive

Company: Thornshaw Recruitment
Reference: TD9209
Closing Date: 18 Nov 16
Type: Permanent
Salary (£): On Application

Job Summary:

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.

The Job:
•    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 - For all vacancies log on to

Apply for this job: Regulatory Affairs Executive

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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