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Job Details

Regulatory Affairs Officer

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD8862
Closing Date: 02 Jan 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

On behalf of our client, a growing pharmaceutical company, we are currently recruiting for Regulatory Affairs Officers

Requirements:

On behalf of our client, a growing pharmaceutical company, we are currently recruiting for Regulatory Affairs Officers. There are a maternity contract cover position and permanent position available. 

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 marketsMaintain assigned products' Marketing Authorisations 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 acc. 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

Requirements:
•    Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree essential
•    1 – 2 year experience in a regulatory affairs environment  desirable
•    1 – 2 year experience in the pharmaceutical industry desirable
•    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 utilised in RA department

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com

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

Apply for this job: Regulatory Affairs Officer

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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