Regulatory Affairs Technician - Global DMF & Dossier Expert

Suanfarma, SA; Castanheira do Ribatejo; Teletrabalho; EUR 35 000 - 45 000; Tempo integral

Resumo da oferta

A pharmaceutical company is seeking an RA Technician in Castanheira do Ribatejo, Lisbon. The successful candidate will support the regulatory team in reviewing documentation, preparing regulatory submissions, and ensuring compliance with international guidelines. A Bachelor's degree in a scientific field and at least 2 years of experience in regulatory affairs are preferred. Strong attention to detail and fluent English are essential for this role, which offers a permanent contract in a collaborative environment.

Qualificações

• Experience in Regulatory Affairs within the pharmaceutical industry is preferred.
• Basic knowledge of ICH, EMA, and FDA regulatory frameworks.
• Fluent in English, both written and spoken.

Responsabilidades

• Support the analysis of technical documentation as per international guidelines.
• Assist in regulatory dossier preparation and lifecycle management.
• Liaise with internal teams to collect regulatory information.
• Maintain accurate regulatory records.

Conhecimentos

Attention to detail

Analytical mindset

Organizational skills

Team collaboration

Proactive attitude

Formação académica

Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related field

Descrição da oferta de emprego

A pharmaceutical company is seeking an RA Technician in Castanheira do Ribatejo, Lisbon. The successful candidate will support the regulatory team in reviewing documentation, preparing regulatory submissions, and ensuring compliance with international guidelines. A Bachelor's degree in a scientific field and at least 2 years of experience in regulatory affairs are preferred. Strong attention to detail and fluent English are essential for this role, which offers a permanent contract in a collaborative environment.