Regulatory Compliance Specialist

3 days ago


Kilkenny, Kilkenny, Ireland Tn Ireland Full time

Company Overview:

Tn Ireland seeks a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for overseeing the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Key Responsibilities:

  • Interact with regulatory agencies to expedite approval of pending registration.
  • Serve as regulatory liaison throughout the product lifecycle.
  • Participate in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).

Requirements:

  • Level 8 degree in engineering or science or related discipline.
  • Min 5 years of experience in a similar position and experience with EU regulatory bodies in regards to applications and submissions or equivalent international experience.
  • Manufacturing operations and manufacturing change experience.
  • Strong attention to detail.
  • Solid communication skills and ability to communicate at all levels.


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