Cork: +353 21 4509200 | Dublin: +353 1 5175910
jobs my account call
Search Jobs
Advanced
to

Regulatory Affairs Associate

Manufacturing / Production
Dublin South
Danielle Francois
Contract
Favourites Share with a friend
Job Reference: JO-2109-65963_1631192567

Summary:

A contract role has come up for one of our clients based in South Dublin. The organisation is a Globally renowned pharmaceutical organisation.

In this role, the successful candidate will support with CMC regulatory registration activities and support the companies' commercial strategies global regulatory plans


Job Summary

The Associate Regulatory Affairs is responsible for the registration document(s) procurement, preparation and coordination.


Key Activities

  • 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 another 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

  • 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 the ability to work within a team environment, but maintain a level of autonomy for managing daily tasks and activities
  • Solid working knowledge of document management systems such as Documentum.

Education & Experience
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

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists


View more Jobs in Manufacturing / Production
Share this job with a friend:
Talent Consultant:
Danielle Francois
Danielle Francois
Senior Talent Consultant
Supply Chain
Ask a question about this job
More jobs from Danielle Francois >
View more Jobs in Manufacturing / Production
Share this job with a friend:
Website Design by Dmac Media