Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Negotiable
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 firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671
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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