Senior Regulatory Affairs Associate
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Regulatory |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3022 |
| Job Views | 781 |
- Description
- Team Horizon is seeking a Senior Regulatory Affairs Associate for a global biotechnology company who are based in Dublin. This is an opportunity to join an experienced team, and work with products and therapies that transform and save lives.
Why you should apply:
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Registration documents procurement, preparation, coordination submission and archival
Coordinates legalization and delivery of registration documents following the instructions provided in the request.
Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
What you need to apply:
Bachelor/Master’s degree (Regulatory, Life Sciences, Biotechnology or related discipline)
MUST have GMP site experience, with regulatory experience and understand Regulatory filings
Excellent written and verbal skills - Knowledge of Good Manufacturing Practices (GMP) and good documentation practices.
Strong written and oral communication skills, You should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
Proficient use of MS Office tools, SharePoint and strong computer aptitude.
Must have ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities
Solid working knowledge on document management systems such as Documentum.
