Job Opportunities in Portugal


August 23, 2022

Basi Laboratórios

Mortágua


Regulatory Affairs Officer (Remote / Hybrid)

Descrição da Função
Laboratórios BASI – Industria Farmacêutica S.A., in Mortágua (Viseu-Coimbra), seeks to integrate a new employee into its Regulatory team:
REGULATORY AFFAIRS OFFICER (m/f)
Main responsabilities:
  • 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; Sm PC; 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 costumers and provide regulatory guidance/documentation support.

Perfil do Candidato
  • 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


Send us your CV to: recrutamento@groupfhc.pt

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