Senior Regulatory Affairs Officer

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Closing date
15 Oct 2020

View more

Discipline
Regulatory Affairs, Regulatory Writing, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
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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. 

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 Linda at +353 1 2784671 or email ldunne@thornshaw.com

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

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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