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Regulatory Compliance Officer

1 week ago

Dublin, Dublin City, Ireland LSC, Life Science Consultants Full time
Tech Transfer Specialist

We are seeking a Regulatory Compliance Officer - Tech Transfer to join our client, a leading biotech company in Ireland. The successful candidate will be responsible for delivering GMP documents related to tech transfer such as risk assessments, change controls, batch records, sampling plans and bills of material.

Key responsibilities include:

  • Managing new program introduction schedules to ensure tasks are executed on schedule and right-first-time.
  • Collaborating with stakeholders to execute transfer requirements of late stage clinical and/or PPQ programs.

About You

  • Minimum 3 years of work experience in the pharmaceutical or biotech industry.
  • Bachelor's degree in Engineering, Biotechnology, Chemistry or related field.
  • Technical knowledge with biologics drug substance upstream and downstream operations or process development.
  • Understanding of New Product Introduction NPI/Tech Transfer principles and activities.