Site Name: LisbonPosted Date: Apr 8 2024Job 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.P.) os processos em cursoAtualização de bases de dados internasAtualização de informação do medicamento: RCM, FI e Rotulagem;Revisão e aprovação de materiais de embalagemApoiar do ponto de vista dos Assuntos Regulamentares os outros departamentos da empresa (ex. qualidade, acesso ao mercado, comercial, supply e Suporte/participação em projectos internosWhy you?Basic Requirements:We are looking for professionals with these required skills to achieve our goals:Licenciatura/Mestrado em Ciências FarmacêuticasBons conhecimentos de Inglês – falado e escritoPreferred 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 preferencialCapacidade de organização e de prioritização, incluíndo especial atenção ao detalheExcelente capacidade de comunicação e facilidade no relacionamento interpessoalForte espírito de equipaDinâmico e com iniciativaPrincipais Áreas de Desenvolvimento:Assuntos Regulamentares, instituições e regulamentação europeia e nacional aplicávelConhecimentos científicos das áreas terapêuticas e medicamentos respectivosJob Posting End Date: 22/04/2024Please 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?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.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/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/ AgenciesGSK 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 GSK's Transparency Reporting For the Record site.#J-18808-Ljbffr
