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Job Details

Senior Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location:
Reference: TD2811
Closing Date: 22 Jul 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

My client is an international pharmaceutical company with offices in Dublin. We are currently recruiting on their behalf for a Senior Regulatory Affairs Specialist. 

Requirements:

My client is an international pharmaceutical company with offices in Dublin. We are currently recruiting on their behalf for a Senior Regulatory Affairs Specialist. 

The Role & Responsibilities:

Critical review of high quality, Chemistry Manufacturing and Control (CMC) detailed regulatory documents and identify any possible deficiencies prior to dossier submission to EU and US Agencies 
Liaising and working closely with other company personnel (R&D, Medical Affairs, Quality, Business Development and Licensing) to ensure accuracy of such documents 
Preparation and submission of MAAs  in conformance with applicable regulatory guidelines 
Providing regulatory support for out-licensing activities in EU, US and international territories 
Liaising with Regulatory Authorities and Affiliates 
Mentoring, training and daily oversight of Regulatory Affairs Assistants and Officers within the regulatory department 
Managing post-licensing activities (variations, renewals, PSURs, Amendments, Supplements, Annual Reports etc.) 
Assist the Head of Regulatory Affairs on complex regulatory strategy issues and help develop solutions with members of the regulatory department and other internal stakeholders. 

Education/Experience: 
3rd level life science or pharmacy degree 
7-10 years relevant EU and ideally US regulatory affairs experience in the pharmaceutical industry. 
Previous exposure to formulation development, CMC and CTD Dossiers for MAA's is essential. Working knowledge of eCTD is an advantage but not essential. 
You should be an organised, motivated and approachable team player who also works well independently. You should also have excellent attention to detail and proven ability to effectively influence within and beyond the group. 
Travel to other sites to work as part of duties will be required. 

This role is a great opportunity for an experienced regulatory professional to learn and develop within a fast growing pharmaceutical company in Ireland. You will have a lot of automony in the role and will be part of the senior team.


If you are interested in applying and discussing the details in further please call Tina on +353 1 2784671 or email tdunne@thornshaw.com 


Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

Apply for this job: Senior Regulatory Affairs Specialist

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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