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Senior Registration Officer

  1. London
London
  1. Permanent
Competitive
  1. CAPEX Projects
01-05-2024
32367
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Senior Registration Officer - Life Science - London

Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland’s picturesque capital? Our esteemed client is looking for a Senior Registration Officer to join their team in their existing manufacturing facility in North Dublin.

The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Senior Registration Officer to help maintain manufacturing operations.


Responsibilities:
  • Coordinate Confirmation of Submission Strategy (CoSS) 
  • Prepare and submit national variations, renewals, responses to questions, or other submissions as required to the National competent UK authorities according to agreed company procedures and objectives (for new and established products) 
  • Provide UK national support for new product MR/DC or CP submissions managed by CRA teams 
  • Liaise with UK the Commercial team to support UK launches, re-launches, switches, and transfers (supply chain, demand/forecasting, marketing, pricing) 
  • Provide regulatory input for designated established products to ensure legal requirements are complied with 
  • Provision of relevant documentation to internal and external customers to allow the release of medical product to the market 
  • Ensure SPPs for UK National licences are maintained and manage Sunset Clause status for all UK Marketing Authorisations in line with local policy and EU regulations 
  • Ensure and maintain product information and artwork for designated UK marketed within the correct system, and reflects current registered versions 

Requirements: 
  • BSc or equivalent in Life Sciences or related area. 
  • Demonstrable experience in Regulatory Affairs – UK submissions.  
  • Effective verbal and written communication skills. 
  • Proven experience in managing large volume and fast paced product portfolios. 
  • Flexible approach to enable prioritisation in line with company requirements. 
  • Proven ability to effectively participate in working groups or cross functional project teams, and successfully collaborate with colleagues. 
  • Computer literacy with Microsoft Office Suite and Documentum-based applications. 

If this role is of interest, please apply now! 

 #LI-KT1
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