Trainee, Regulatory Affairs

Hikma; Viseu; Presencial; EUR 18 000 - 26 000; Tempo integral

Resumo da oferta

A Hikma, fundada há mais de 40 anos por Samih Darwazah, dedica-se a fornecer medicamentos de alta qualidade a preços acessíveis. Em Portugal emprega mais de 1.000 pessoas e opera três unidades de fabrico dedicadas a medicamentos injectáveis.

Procuramos um Trainee de Regulatory Affairs (m/f) para ingressar no departamento de Regulatory Affairs, em regime on-site. Requisitos: mestrado em Ciências Farmacêuticas, 0–2 anos de experiência, fluência em inglês e fortes competências de apresentação e

Qualificações

• Mestrado em Ciências Farmacêuticas.
• 0–2 anos de experiência em Regulatory Affairs.
• Fluência em inglês e excelentes competências de apresentação.
• Responsabilidade, proatividade e espírito de equipa.
• Organização e planeamento.

Responsabilidades

• Gestão de atividades pós-aprovação relacionadas com ANDAs e MAAs (relatórios anuais e variações).
• Criação de Change Controls para implementação de rotulagem.
• Fornecer informações para APRs, criação e revisão de SOPs e DHFs quando aplicável.
• Apoiar o site no lançamento de novos produtos, realizando todas as atividades regulatórias necessárias.

Conhecimentos

English proficiency

Presentation skills

Communication skills

Teamwork

Formação académica

Mestrado em Ciências Farmacêuticas

Descrição da oferta de emprego

Descrição do cargo

Founded over 40 years ago by Samih Darwazah in Jordan, Hikma’s purpose is to provide high-quality and affordable medicines to the people who need them. Built on strong foundations, we continue to innovate every day and find practical solutions that transform the lives of the millions of people we serve.

In the late 1980s, we extended our reach beyond the Middle East and acquired land in Portugal to build a manufacturing facility for sterile injectable pharmaceutical products. This marked a major turning point for the company and represented our first step into a new region. Today, in Portugal, we employ more than 1,000 people and operate three manufacturing sites dedicated to injectable medicines.

Hikma is looking to recruit a Trainee, Regulatory Affairs (m/f) to join Regulatory Affairs department on an on-site basis.

Main Responsibilities

• Handling of post-approval activities related to Abbreviated New Drug Applications (ANDAs) and Marketing Authorizations Applications (MAA), in specific Annual Reports and variations.
• Create Change Controls for implementation of Labeling.
• Provide information for Annual Product Review (APRs), creation and revision of internal SOPs and DHFs whenever applicable.
• Support the site with the launch of new products, by performing all regulatory activities required.

Candidate Profile

• Master's degree in Pharmaceutical Sciences
• 0-2 years of Regulatory Affairs experience
• Fluency in English, as well as strong presentation and communication skills.
• Responsibility, proactivity and team work.
• Organization and planning capabilities.
• Ability to work under pressure and to meet deadlines.

What We Offer

• Initial and ongoing training within a dynamic and positive environment.
• Professional development and career growth opportunities.
• The opportunity to gain knowledge and best practices within a rapidly expanding international group.

If you believe this is a great opportunity for your professional career, join us and help contribute to Better Health, Within Reach, Every Day.