Senior Regulatory Affairs Officer

Thornshaw Recruitment
Dublin (City), Leinster (IE)
Closing date
15 Oct 2020

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Regulatory Affairs, Regulatory Writing, Project Management, Regulatory Project Management
Full Time
Contract Type
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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. 


  • 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 Linda at +353 1 2784671 or email

Thornshaw Scientific is a division of the CPL group

Thornshaw Scientific Recruitment has been providing a reputable recruitment service to the Biopharmaceutical, Pharmaceutical, Clinical Research, Medical Device, Food and Healthcare industries for over 15 years.

Our strategic focus has always been to grow the business in a way which has ensured the quality of our service has never been compromised. In 2005 Thornshaw was acquired by Cpl Resources, one of Europe’s most successful recruitment companies.

Contact Us
  • Barton House
  • 6 Old Dublin Road
  • Co. Dublin
  • IE
  • 00 353 (1) 278 4671
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