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Job Details

Regulatory Affairs Officer Submissions

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD8861
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 for submissions. These are for permanent and 12 month contract opportunities.

Requirements:

On behalf of our client, a growing pharmaceutical company, we are currently recruiting for Regulatory Affairs Officers for submissions. These are for permanent and 12 month contract opportunities. 

Role:
•    Assessment of the content and format of RA documents vs. registration requirements and guidelines.
•    Coordination & preparation of regulatory submissions 
•    Negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
•    Foster good working relationships with relevant regulatory bodies.
•    Ensure that timely responses to the regulatory queries raised during the evaluation process 
•    Ensure all activities are within the framework of the Quality system, including the setting and achievement of relevant KPIs. 

Requirements:
•    A minimum of relevant Life Science degree and/or a minimum of 1 years EU Submissions experience. 
•    Working knowledge of EU regulatory requirements and procedures required. This includes good understanding of CMC and eCTD requirements.
•    Solid knowledge of IT tools specific for in RA and pharmaceutical sector (as eCTD, databases, change control management etc.) required.
•    Experience of working in accordance with quality standards e.g. GMP
•    Strong team member with the ability to identify and drive quality improvements
•    Good administrative/organisational ability with attention to detail is required.
•    Be able to work autonomously and have good problem solving skills.

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 Submissions

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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