RA Technician

Suanfarma, SA; Castanheira do Ribatejo; Vor Ort; EUR 35.000 - 45.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Analytical mindset

Organizational skills

Team collaboration

Proactive attitude

Ausbildung

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

Jobbeschreibung

### **RA Technician*** Country: PORTUGAL* Workplace:* Type of contract: Permanent* Date publish: 23/03/2026* Timetable:* Vacancies: 1#### **Job description**At SF CDMO, we are looking for an individual eager to grow within our RA team in Castanheira do Ribatejo, Lisbon.RESPONSIBILITIES:Support the global review and analysis of technical documentation, including Drug Master Files (DMFs), in accordance with international guidelines (ICH, EMA, FDA, etc.).Assist in the preparation, compilation, and maintenance of regulatory dossiers and documentation.Collaborate with global senior team members in the implementation of regulatory strategies across the product lifecycle.Support the coordination of DMF submissions, updates, and lifecycle management with health authorities.Liaise with international internal teams (Quality, R&D, Supply Chain, Commercial) to collect and verify regulatory information.Assist in responding to global regulatory queries from authorities and clients under supervision.Support international clients in regulatory activities related to the inclusion of Suanfarma as an API supplier in their products.Maintain accurate regulatory records and ensure proper documentation within internal systems.Monitor changes in international regulatory requirements and support the team in assessing their impact.Contribute to ensuring compliance with internal procedures and regulatory standards.REQUIREMENTS:Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.Previous 2 years of international environments in Regulatory Affairs (pharmaceutical industry preferred).Basic knowledge of regulatory frameworks (ICH, EMA, FDA) is desirable.LOCATION:Castanheira do Ribatejo, LisbonLANGUAGES:Fluent in English (written and spoken).SKILLS:Strong attention to detailAnalytical mindsetGood organizational and documentation skillsAbility to work in a team and collaborate across functions.Proactive attitude and willingness to learn.#### **Requirements**#### **Registration status**Status:Registered: