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Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Regulatory Affairs Associate


Reference:RH/AVFW684886 Location: Dublin South
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Life Science Recruitment are recruiting a Regulatory Affairs Associateto join the team with ourPharmaceuticalclient based inSouth Dublin.

Group Purpose
Support the coordination, development and/ or execution of CMC regulatory registration activities in accordance with site commercialization strategies and global regulatory plans.

Job Summary

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

The Associate Regulatory Affairs 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.

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 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.

    Knowledge and Skills
  • Bachelor/Master’s degree (Regulatory, Life Sciences, Biotechnology or related discipline)
  • 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
For more information contact Ruth Holland on 087 7822198 or [email protected]