Senior Pharmaceutical Document Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €40,000 - €60,000
Regulatory Operations Professional

Xeolas is a specialty pharmaceutical company.

  • We develop and manufacture innovative patient-friendly pharmaceutical products for international markets.
Job Overview:

The Regulatory Operations Associate will report directly to the Regulatory Affairs Manager and be responsible for ensuring the accurate and timely submission of electronic regulatory documents.

  1. Provide support for submissions by performing tasks such as document preparation, scanning, and printing.
  2. Responsible for all aspects of publishing submissions, including formatting, editing, reviewing, publishing, production, and archiving.
  3. Prepare published output for paper or electronic formats, ensuring high-quality documents in adherence with regulatory guidelines and internal processes.
  4. Maintain submission components associated with a regulatory submission, including templates, procedures, and project tracking.
  5. Assemble electronic and paper Regulatory Submissions and packages using software.
  6. Perform quality review on submission documents to ensure accuracy and completeness.
  7. Manage project workflow throughout the submission process, prioritizing project objectives and overseeing progress with team members.

Key Skills/Experience Requirements:

  • Bachelor's degree 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.
About Our Company:

We are an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with over 70 employees.

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