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Life Science Recruitment

Regulatory Affairs Manager

Life Science Recruitment

  • Kerry
  • Not disclosed
  • Contract
  • Updated 07/10/2017
  • Sinead Cullen
this job is expired
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Description

Our client requires a Regulatory Affairs Manager to joint their team on a permanent basis.There is the opportunity to work remotely with this role.

 

Regulatory Affairs Manager 
Our client requires a Regulatory Affairs Manager to joint their team on a permanent basis. The ideal candidate will have excellent experience in the area of EU filing for Part 2 dossiers and the CMC portion of licence application.  

Responsibilities
• Project management for US applications to FDA for a NADA and to secure further marketing authorisations internationally
• Provide regulatory support for out¬licensing activities in EU and non¬EU territories
• Auditing registration dossiers for the EU in order to evaluate and identify any
possible deficiencies prior to assessment
• Liaising with Regulatory Authorities and Affiliates
• Mentoring and daily oversight of Regulatory Affairs Associates and Officers
• Managing post -licensing activities (variations, renewals, etc.)

Requirements
• Life science , Pharmacy or Veterinary degree
• Minimum of 5 years EU pharmaceutical regulatory affairs industry experience
• Knowledge and prior experience in EU filing of Part 2 dossiers for Injectable sterile products is required
• Excellent attention to detail
• Highly organised, motivated and approachable team player


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252


PLEASE APPLY DIRECTLY BY CLICKING HERE


Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.


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Ref: SC/HQ00001959
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