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.
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.
Regulatory Affairs Senior Specialist
- Ensuring that regulatory affairs programmes and projects are delivered to our high standards. Providing local Irish regulatory expertise to regulatory programmes and projects being managed by PharmaLex UK/Ireland and other international offices
- Professional interaction with the Irish regulatory authority
- Technical support to business development
- Ensuring that clients’ budgetary expectations are appropriately managed
- Accurate time reporting
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 local Irish Regulatory Affairs, devising and implementing successful local regulatory strategies for post-authorisation procedures and launch preparation. 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, quality and supply chain organisations. Previous exposure to reviewing promotional material and the healthcare compliance codes would be an advantage. First-class communication skills and a diplomatic, client-orientated manner are essential. Regulatory affairs experience with a background in regulatory CMC, labelling 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.
For further information please don’t hesitate to contact us:
Agencies only by prior agreement for the specific job opportunity.