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Job Details

Senior RA Submissions Professional

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD9317
Closing Date: 18 Feb 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Senior Regulatory Submissions Management Professional. This role is based within the Regulatory Submissions Management Department in Dublin.

Requirements:

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Senior Regulatory Submissions Management Professional. This role is based within the Regulatory Submissions Management Department in Dublin.  
The primary focus of the Submission Management Professional is to manage and facilitate the delivery of submissions within a given product/asset.  This position is the overall accountable and responsible for project managing individual submissions under an asset.  

Key Aspects of the Role Include:
Plan

  • Responsible for preparing the Regulatory Submissions Pipeline
  • Responsible for verifying and sending project request to company sourcing partner
  • Review proposal from companys sourcing partner in relation to submission plan/approach (e.g. applicable countries, wave approach for roll-out etc.) and provide input and information about priority and start-up date
  • Estimate resources to be spend in submission management

Prepare 

  • Responsible for preparation of submissions 
  • Responsible for liaising with RA content owners and relevant contributing functions to secure relevant documents and submission components for the dossier  
  • Author and review M1 documents

Compile & Publish

  • Responsible for coordinating review of published output with contributing functions
  • Responsible for ensuring the coordination of the delivery of samples

Dispatch & Submit

  • Responsible for ensuring that the dossier is submitted to the HA Proactively  follow up with sourcing partner on submission status and communicate status to relevant stakeholders 

HA Review

  • Responsible for facilitating and managing the HA review process
  • Estimate impact of HA question, prepare for response activities and secure relevant input from RA content owners according to timelines 

Case Closure

  • Responsible for ensuring that the submission progress is managed till approval and Case Closure 
  • Follow up with companys sourcing partner to ensure on-plan HA approvals 
  • Review HA approval/rejection received including commitments

Experience & Qualifications

  • Scientific Master degree, bachelor degree or similar work experience
  • Several years of experience working within Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA or similar)
  • Preferably training/courses within Regulatory Affairs and project management
  • Typically some years of experience working within Regulatory Affairs
  • Understanding of CMC and Labelling components for post-approval activities
  • Knowledge and preferably experience within Submission Management in relation to submission processes 
  • Strong and solid project manager skills (especially solid Communication, collaboration and presentation skills as well as Planning and delegation skills; strong ability to manage a submission pipeline, keep the overview and prioritise; strong drive and ability to execute according to plan and get others to do the same – also for more complex projects, KPI and timeline driven)

Furthermore, you are:
a strong communicator - passionate and enthusiastic in your way of working - a professional with positive and proactive influencing skills - a strong and proactive team player who thrives on working in an international environment

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 RA Submissions Professional

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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