Regulatory Affairs Trainee
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Site Name: Lisbon
Posted Date: Jun 30 2025
A GSK é uma companhia farmacêutica global, impulsionada pela ciência, com um propósito especial: ajudar as pessoas a fazerem mais,
- se melhor e viverem mais tempo.
Temos duas áreas globais de negócio, dedicadas à investigação, desenvolvimento e fabrico de medicamentos inovadores e vacinas.
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.
Funções:
- 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)
- Suporte/participação em projectos internos
- Licenciatura/Mestrado em Ciências Farmacêuticas
- Conhecimento de Assuntos Regulamentares (Pós-Graduação, etc) – requisito preferencial
- Bons conhecimentos de Inglês – falado e escrito
- 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
- Assuntos Regulamentares, instituições e regulamentação europeia e nacional aplicável
- Conhecimentos científicos das áreas terapêuticas e medicamentos respectivos
Aviso Importante aos parceiros e consultorias
A GSK não autoriza o uso dos dados desse site, sem que essa parceria seja firmada em contrato através da área de compras e RH. A obtenção de autorização prévia por escrito é uma condição a qualquer acordo (verbal ou escrita) entre a consultoria e a GSK. Na ausência de autorização por escrito as ações desenvolvidas pela consultorias ou parceiros devem ser considerada como tendo sido realizada sem o consentimento ou acordo contratual da GSK,
- a como responsável por quaisquer ações.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata. cms. gov/
Seniority level
Seniority level
Not Applicable
Employment type
Employment type
Full-time
Job function
Job function
LegalIndustries
Pharmaceutical Manufacturing
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Empresa: GSK Localização: Lisboa
Lisboa, Lisboa, PortugalPublicado: 9. 7. 2025
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