We are growing, grow with us!
PharmaLex has created this exciting, new opportunity for an experienced Regulatory Affairs professional to join our growing team in Ireland. 
The position is  based in our office in Portmarnock in County Dublin. Knowledge of Irish  Regulatory market is essential. 

PharmaLex is one of the largest providers of regulatory affairs, development consulting, quality management & compliance and pharmacovigilance services worldwide.  Our global teams of experts lead clients through early stage strategic planning activities, non-clinical requirements and clinical development, regulatory submission processes and finally guide them to market approval, after which our support extends into product maintenance activities.  As a global organisation with over 31 offices in 17 countries, our reputation, client-base and international footprint continue to grow, making it a very exciting time to join PharmaLex.  With excellent local and international collaboration, the associated project work is diverse and rewarding. 

Senior Regulatory Affairs Specialist

Your Job

  • Ensuring that regulatory affairs programmes and projects are delivered to our high standards.
  • Providing regulatory expertise to regulatory programmes and projects being managed by PharmaLex UK/Ireland and other international offices. Therefore excellent knowledge of the Irish regulatory market is a must 
  • Professional interaction with regulatory authorities.
  • Technical support to business development.
  • Ensuring that clients’ budgetary expectations are appropriately managed.
  • Accurate time reporting.
Given the nature of the role, some EU and international travel can be expected. 

Your Profile

The successful candidate will need to demonstrate the experience and skills to build on our strong reputation for excellence in pharmaceutical regulatory affairs.  Candidates should be experienced to at least senior specialist level and bring sound experience in devising and implementing successful regulatory strategies for post-authorisation procedures. You should have experience of interacting with the HPRA and good knowledge of national regulatory requirements in Ireland, in addition to the ability to interact with clients’ commercial and supply chain organisations.  EU regulatory experience, first-class communication skills and a diplomatic, client-orientated manner are essential.  Regulatory affairs experience supporting other regions, a background in regulatory CMC and/or experience with medical devices or cosmetics would be an advantage. The minimum qualification is a degree in a relevant scientific discipline. 

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

Agencies only by prior agreement for the specific job opportunity.