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Regulatory Operations Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €45,000 - €60,000
Regulatory Operations Role

The Regulatory Operations Associate is responsible for ensuring the accurate and timely submission of electronic regulatory documents.

  • Provide support for submissions by performing tasks such as photocopying, scanning and printing, assembly, dispatch and coordinating resources.
  • Responsible for publishing submissions and/or submission components for internal review and signoff.
  • Preparation of high-quality documents in adherence with regulatory guidelines and internal processes within established time lines.
  • Maintain submission components associated with a regulatory submission.
  • Assemble electronic and paper Regulatory Submissions using Lorenz software.

Key Requirements:

  • Bachelor's degree or related field in Health Sciences or equivalent relevant experience and training.
  • 3-5 years pharmaceutical regulatory industry / regulatory operations experience.
  • Experience working with current eCTD standards is required.
  • Understanding of applicable regulations and guidelines documents.

The ideal candidate will have excellent communication and project management skills, with the ability to work effectively in a team environment.

Key Skills:

  • Excellent Communication
  • Project Management
  • Teamwork
  • Time Management
  • Attention to Detail