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REGULATORY AFFAIRS PROFESSIONAL

 

Company:

CPL
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Job Reference Number

14564892

Client ID:

RI/JO-1112-240005B
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Posted On:

Feb 2 2012

Location:

TIPPERARY
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Job Type:

Contract

Salary:

NEGOTIABLE
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CPL Cork has been retained by one of their key clients to partner in the sourcing and selection of a Regulatory Affairs Professional.

Duties and Responsibilities: · Regulatory responsibility for a portfolio of products and be responsible for close liaison with the Management/other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.

· Proposes and implements effective strategies to minimise the timing of and optimise the commercial viability of product licenses.

· Responsibility for the preparation of Package Leaflet User-Test or Bridging Reports.

· Builds and maintains strong relationships with EU Competent Authority to ensure ease of access and influence.

· Provision of guidance/technical support in the preparation of EU CTD dossiers applications including eCTD & NeeS submissions

· Support other team members with the implementation of the QMS and objectives to achieve ISO 9001

Candidate Requirements:

Minimum of a degree in Science 3 + years experience in Regulatory Affairs in the Pharmaceutical Industry or medical device Industry. Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice. Strong knowledge of the national and EU regulatory framework. Excellent written and oral communication skills and the ability to project manage across a diverse and complex portfolio of products and priorities. If you are interested in hearing more about this opportunity, please call Rory Walsh, Senior Recruitment Consultant, for a confidential discussion on 021 4626112, or send your cv to rory.walsh@cpl.ie .

If you are not interested in this role but you would like to hear about future opportunities in the Pharmaceutical and Biotechnology Industries in Munster, please feel free to send your cv to rory.walsh@cpl.ie .

I will look forward to hearing from you.