Senior Regulatory Affairs Officer

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Job Description

My client, a global healthcare company now have a vacancy for a Senior Regulatory Affairs Officer.

Your role:

You will provide regulatory affairs support to support and manage International MAAs and Lifecycle activities for our current and actively growing range of pharmaceutical products, CAMs, our R&D pipeline products’ therapeutic indications and international markets. 

Responsibilities:

  • Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, CAMs and ad hoc R&D pipeline)
  • Preparation and filing of submissions including; life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing.
  • Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
  • Support the strategic and operational planning and registration of CAMs in global markets
  • Actively participates and employs effective communication practices with internal customers (CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).
  • Prepare status reports and metrics for assigned projects
  • Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
  • Any other duties as assigned by your Manager
  • Promote best regulatory practice and approach in business operations
  • Promote and develop best use of regulatory tools and e-platforms
  • Support Change Control and Quality Management process within GRA • Any other duties as assigned on ad hoc basis  

 

Education and Experience:

  • >3 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)
  • Experience of EU DCP and MRP MAAs
  • Experience of emerging markets / international Row markets and regulatory filings is
  • Quality control review of technical/ regulatory documents
  • Understanding of Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices
  • Publishing: eCTD Office and or NEES – an advantage
  • IT Literate and working familiarity with regulatory publishing platforms
  • Project management experience

Experience of CAMs/Food Supplements/Borderline/Nutritional products – advantageous

 

For full details contact Tina at +353 1 2784671 or email tdunne@thornshaw.com

Thornshaw Scientific is a division of the CPL group www.thornshaw.com

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    Linda Dunne

    Senior Recruitment Consultant ldunne@thornshaw.com
    • Salary:Negotiable
    • Location:Dublin City Centre
    • Type:Permanent
    • Category:Science,Thornshaw
    • Ref.no:JO-1902-424841._99