Senior RA Specialist
- Posted 13 May 2019
- SalaryUp to €56000 per annum
- Job type Permanent
- DisciplineLife Sciences & Engineering Technologies
- ReferenceBBBH25807_1557741136
- ContactSorcha Hayward
Job description
My client are a global clinical pharmaceutical company headquartered in the US. They are focused on the development, approval, and commercialization of specialty products, including a line of generic dermatology products and injectable oncology products. Due to growth and success, they are currently expanding their Dublin operation and seek to hire a Senior Regulatory Affairs professional to join their team on a permanent basis.
The role:
Reporting into the Director of Regulatory Affairs, you will liaise heavily with the U.S arm of the organisation and will be responsible for:
- Drafting, preparing and reviewing regulatory documentation for EU and international dossier submissions
- Monitoring progress of registration submissions
The person:
- Degree qualified in a pharmaceutical/technical discipline
- 5 years industry experience with relevant technical experience (QA, Tech Ops, R&D, Manufacturing)
- At least 2 years RA experience
- Experience with Module 3 CMC authoring
- Experience with the electronic submission system (eCTD)
- Understanding of requirements for sterile injectables or drug device combination products desirable
The benefits:
- Competitive salary
- Bonus
- Healthcare
- Pension
- Excellent career development and learning opportunities
To find out more, email or call + 353 1 6321866 for a confidential discussion