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Regulatory Operations Specialist

3 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

Dublin, Ireland - Permanent Full Time Role

Job Overview

This role is focused on ensuring the accurate and timely submission of electronic regulatory documents for existing licensed products for life cycle maintenance and new submissions.

The Regulatory Operations Associate will report directly to the Regulatory Affairs Manager and have a range of responsibilities including support for submissions and other documents by performing necessary tasks.

Main Responsibilities
  • Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning, printing, assembly, dispatch, and coordinating resources for submissions.
  • Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
  • Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines.
  • Maintain submission components associated with a regulatory submission, paper and/or electronic, as required.
  • Assemble electronic and paper Regulatory Submissions and packages for European, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using Lorenz software.
  • Perform quality review on submission documents to ensure accuracy and completeness.
  • Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required.
Key Skills and Qualifications
  • 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.
What We Offer

This role offers opportunities for growth and development in a dynamic and innovative environment. The ideal candidate will have excellent communication and organizational skills, and be able to work effectively in a team environment.

About the Role

This role is an exciting opportunity to join our organization and contribute to the success of our team. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.