Regulatory Affairs Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeResponsibilities Full time €75,000 - €90,000

We are seeking an accomplished Regulatory Operations Specialist, to play a pivotal role in ensuring the seamless submission of electronic regulatory documents.

  • The ideal candidate will have experience with eCTD publishing tools and software, as well as a strong understanding of applicable regulations and guidelines.

Key Responsibilities:

  1. Provide support for submissions by performing tasks such as photocopying, scanning, and printing, assembly, dispatch, and coordinating resources.
  2. Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
  3. Prepare high-quality documents in adherence with regulatory guidelines and internal processes within established time lines.
  4. Maintain submission components associated with a regulatory submission, paper and/or electronic.
  5. 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.
  6. Perform quality reviews on submission documents to ensure accuracy and completeness.
  7. Manage project workflow throughout the submission process, prioritizing project objectives, and overseeing progress of projects with other team members.

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.
  • Strong organizational skills, attention to detail, and ability to work independently and collaboratively as part of a team.

Benefits:

  • This role offers opportunities for growth and development in a dynamic and fast-paced environment.
  • Professional training and mentorship to enhance skills and knowledge.
  • Collaborative and supportive team environment.

Skills and Qualifications:

  • eCTD publishing tools and software.
  • Pharmaceutical regulatory industry experience.
  • Regulatory affairs and operations management.
  • Project management.
  • Quality assurance and control.

Apply Now: If you are a motivated and detail-oriented individual with experience in regulatory operations, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to us today.

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