Job Type: Contract
Job ID: JO-2111-28236
Consultant: Karen McHugh
Are you a Regulatory Affairs specialist with 3+ years GMP site experience , with some sort of reg experience and have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)?
If interested, contact Karen for further information or send your CV to email@example.com for review.
Regulatory Affairs Specialist - Biotech - Dublin
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience on Ireland's leading aseptic manufacturing plant.
Support the coordination, development and/ or execution of CMC regulatory registration activities in accordance with company's commercialization strategies and global regulatory plans.
You will be responsible for the registration document(s) procurement, preparation and coordination.
You will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.
Works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed.
Registration document(s) 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.
Bachelor/Master’s degree (Regulatory, Life Sciences, Biotechnology or related discipline)
Candidates MUST have GMP site experience , with some sort of reg experience
Candidate needs to Regulatory filings at least
Excellent written and verbal skills
Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
Strong written and oral communication skills
The applicant 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.
Contract rate of €25 - €35 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you are Regulatory Affairs Specialist interested in roles based in Dublin, you can contact Karen by e-mail firstname.lastname@example.org or phone +353-1-7978720 for a confidential chat.
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