Senior Regulatory Affairs Officer
Global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life.
As Senior Regulatory Affairs Officer to be based within the Quality Department – you will be responsible for the following:
- To Obtain and maintain Marketing Authorisations (MA’s) and Clinical Trial Authorisations (CTA’s) for a designated list of products.
- To maintain an awareness of current Irish & EU regulatory requirements.
- Deputise in the absence of the Head of Regulatory Affairs.
- To submit applications (new MA’s/Clinical Trials/Variations/Renewals etc.) for National/EU MA ‘s and negotiate with the HPRA to resolve any issues to minimise the delay in approval.
In order to be considered for this role you must possess the following:
- A Third level degree qualification in Life Science or similar
- 2-4 years regulatory affairs / compliance experience working within the Pharmaceutical or Biotechnology industry sectors.
- Knowledge and exposure to the HPRA and knowledge of the Irish Market.
- Excellent team working and communication skills.
- Strong negotiation, influencing, presentation skills.
- Strong visionary, strategic, tactical and motivational skills.
- Eligible to work within EU?
- Competitive salary – may vary based on experience
- Life insurance
- Pension scheme
To learn more, apply online or contact Gillian McMurrough +353 1 6321827 for a confidential chat.
Salary: €45000 - €65000
Location: Dublin West