Regulatory Affairs Specialist - Biotech - Dublin


Location: Ireland

EUR 25 - 35 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

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 karen@jobcontax.com for review.


Regulatory Affairs Specialist - Biotech - Dublin


Job Description

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.


Requirements 

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.


Package

Contract rate of €25 - €35 per hour

Minimum 12 month contract


Contact

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 karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.


JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Regulatory Affairs Specialists in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.


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