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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