Description
Regulatory Compliance officer:An exciting opportunity has arisen within a top 10 generics pharmaceutical company. They are looking to hire a number of regulatory Compliance officers to join their global regulatory compliance team in their Dublin office.
The role will involve:
You will be involved in CMC dossier compilation
Responding to questions and inquiries from the regulatory bodies and health authorities
Liaising with affiliates
Change management
Managing dossier lifecycle
Process development
Writing SOP's.
Working on a compliance team of 8
Working alongside the regulatory submissions team
Problem solving, gap analysis and gap remediation
Experience required:
Minimum two to three years experience in regulatory affairs with compliance experience
CMC experience - someone who has compiled dossiers
Familiarity with validating manufacturing documents
Experience with Trackwise and / or Documentum,
Change Control
Experience managing change from start to finish
Advanced Excel skills are nice to have
Familiarity with CTD
Ideally someone from a manufacturing / lab background with experience reviewing and writing technical documents
Experience with manufacturing transfers is nice to have
Project experience is nice to have
The type of person required:
Someone who can work independently
Ideally someone with experience in generics
An ability to prioritise a busy workload
Excellent communication skills
Strong verbal and written English
Someone who is flexible and adaptable
Why this company:
Working for this company will give you the opportunity to be involved in different areas, get involved with different functions and to really get to give your input
There are huge learning and development opportunities. There is a real sense of achievement as this company rapidly expands and works through their ambitious expansion and growth plans. The company invests in their staff in terms of training and development and there are strong career opportunities to progress.
Package:
An excellent salary of between €40,000 and €50,000 depending on experience is on offer. An excellent benefits package including health insurance, 7.5% employer contribution for pension, significant bonus, 23 days annual leave and flexibility around start and finishing times is offered. This is a permanent role.
Interviews will be immediately (first round phone interview followed by one face to face). If you are interested in this role please send me Tracey English an updated CV for immediate consideration or call me on for more information.