REGULATORY AFFAIRS TRAINEE

Descripción del puesto.
Job Purpose.
O estágio na área regulamentar tem a duração de 12 meses com o objetivo de proporcionar ao candidato o primeiro contato com o "mundo" empresarial, dotando de conhecimento prático relacionado com os diferentes processos de gestão da área de Assuntos Regulamentares.
In this role, you will...
* Preparação e submissão de alterações aos termos de AIM de medicamentos (procedimento nacional, MRP, DCP) * Acompanhar junto da Autoridade Regulamentar (INFARMED, I.
.) os processos em curso * Atualização de bases de dados internas * Atualização de informação do medicamento.
RCM, FI e Rotulagem; * Revisão e aprovação de materiais de embalagem * Apoiar do ponto de vista dos Assuntos Regulamentares os outros departamentos da empresa (ex.
qualidade, acesso ao mercado, comercial, supply e Suporte/participação em projectos internos Why you? Basic Requirements.
We are looking for professionals with these required skills to achieve our goals.
* Licenciatura/Mestrado em Ciências Farmacêuticas * Bons conhecimentos de Inglês - falado e escrito Preferred Requirementes.
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply.
* Conhecimento de Assuntos Regulamentares (Pós-Graduação, etc) - requisito preferencial * Capacidade de organização e de prioritização, incluíndo especial atenção ao detalhe * Excelente capacidade de comunicação e facilidade no relacionamento interpessoal * Forte espírito de equipa * Dinâmico e com iniciativa Principais Áreas de Desenvolvimento.
* Assuntos Regulamentares, instituições e regulamentação europeia e nacional aplicável * Conhecimentos científicos das áreas terapêuticas e medicamentos respectivos Job Posting End Date.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Why Us? (COMPANY NAME) is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.
billion people by the end of .
Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making (COMPANY NAME) a place where people can thrive.
We want (COMPANY NAME) to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
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