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Job Details

Regulatory Affairs Officer - Pharma and Medical Devices!

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD8480
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Negotiable

Job Summary:

Our client, a growing Dublin based pharmaceutical company are currently recruiting for a Regulatory Affairs Officer for medical devices.


Our client, a growing Dublin based pharmaceutical company are currently recruiting for a Regulatory Affairs Officer 

Main Objective of Role

Ensure timely preparation and compilation of registration dossier for assigned projects in accordance to EU standards and corporate requirements
Manage international regulatory submissions according to company strategy and ensure meeting registration  deadlines, via timely answering Health Authorities'  queries and deficiencies as well as via close cooperation  with other involved functions and liaison with Regulatory Authorities, in order to support the timely introduction of new product into markets
Maintain assigned products' Marketing Authorizations via timely variations and renewals submissions and their approvals
Build departmental awareness of local regulatory requirements in global markets
Compile regulatory component of annual product review and PSUR
Archive the registration  documentation  ace. To internal standards; introduce and regular up-dates to the internal RA database
Perform assigned tasks with the highest quality and in accordance to established internal timelines.


•    Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
•    1-2 year experience in a regulatory affairs environment
•    1- 2 year experience in medical devices and pharma.
 •    Detailed knowledge of EU current registration requirements for dossier preparation and procedure running
•    Deep knowledge of specific national requirements in usual target registration countries
•    General knowledge of the pharmaceutical industry
•    Knowledge of Company's internal rules, SOPs and structure
•    Knowledge of IT tools utilized in RA department

For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671

Apply for this job: Regulatory Affairs Officer - Pharma and Medical Devices!

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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