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Job Details

Senior Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD9524
Closing Date: 09 Sep 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global pharmaceutical company, are currently recruiting for a Senior Regulatory Affairs Specialis

Requirements:

Our client, a global pharmaceutical company, are currently recruiting for a Senior Regulatory Affairs Specialist.

Responsibilities will include: 

  • 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 (e.g. generic/bibliographical) in the EU via national, MRP, DCP routes and ANDAs and NDAs (mainly 505(b)(2)) projects) in the US 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
  • Travel to other sites and head office in Europe required

Requirements

  • Relevant 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. 
 

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: 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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