Regulatory Affairs Trainee - Lisboa, Portugal - GSK
Descrição
Site Name:
Lisbon
Posted Date:
Apr 8 2024
Job Purpose:
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.P.) 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
Why Us?
GSK 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 2.5 billion people by the end of 2030.
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 GSK a place where people can thrive.
We want GSK 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.
We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
GSK is an Equal Opportunity/Affirmative Action Employer.All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements.
For more information, please visit GSK's Transparency Reporting For the Record site.Mais empregos da GSK
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