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; 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 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: ******

#J-18808-Ljbffr