Regulatory Affairs Specialist

3 semanas atrás

Viseu, Portugal Basi Laboratórios Tempo inteiro

Job Summary

Basi Laboratórios is seeking a highly skilled Regulatory Affairs Officer to join its team. The successful candidate will be responsible for preparing and submitting MA variations for medicinal products, ensuring compliance with relevant legislation and internal requirements.

Main Responsibilities

  • Prepare and submit MA variations for medicinal products (national procedure, DCP, MRP).
  • Prepare, review and update MA dossier, ensuring compliance with relevant legislation and internal requirements.
  • Update Product Information (PIL; SmPC; labelling) and AW review.
  • Lead interaction with Regulatory Authorities and provide support in regards to regulatory information requests.
  • Reply to deficiency letters that may arise from Regulatory Authority evaluation of variations.
  • Support strategic discussion with internal departments identifying regulatory needs/timelines and being responsible for regulatory strategy definition.
  • Coordination of local regulatory projects and ensure the proper ant timely management of regulatory aspects.
  • Interaction with external customers and provide regulatory guidance/documentation support.

Requirements

  • Graduation or Master Degree in an area relevant to the function.
  • Knowledge of Good Manufacturing Practices, Guidelines and Standards
  • 2 years of experience in similar or relevant functions

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