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Chief Regulatory Documentation Specialist

2 weeks ago

Cork, Cork, Ireland beBeeDocumentations Full time €60,000 - €100,000
Regulatory Documentation Specialist

The primary responsibility of this role is to support the completion of Module 1 CMC-related information for all submissions where CMC support is required.

  • Develop and utilize appropriate Information management expertise to support regulatory documentation, ensuring compliance with industry standards and guidelines.
  • Coordinate global registration activities and request/provide necessary documentation in a timely and efficient manner.
  • Prepare updates to CMC CTD content consistent with approved manufacturing changes, utilizing knowledge of pharmaceutical drug development and industry-related experience.
  • Communicate and adhere to document naming convention and classifications requirements, maintaining accurate and up-to-date records.

Key Responsibilities:

  • Monitor and track CMC Submission mailbox to ensure prompt response to inquiries and submissions.
  • Prioritize submissions based on due dates, managing workload effectively to meet deadlines.
  • Oversee and manage activities to register new products and renew existing products in global markets, fostering strong relationships with internal and external stakeholders.

Requirements:

  • Bachelor's Degree in a scientific or health sciences discipline, with a focus on pharmaceutical science or a related field.
  • Knowledge of pharmaceutical drug development or industry-related experience preferred, with ability to operate and manage operational requirements in a regulated environment.