Regulatory Affairs Trainee

Job description

Position Summary You will join our Regulatory Affairs team in Portugal as a trainee for a 8-month programme. You will act as the dedicated resource for a key internal project, taking ownership of the regulatory activities required to support its successful implementation. We value curious learners, strong communicators and people who pay attention to detail. This role offers guided learning, real responsibility and the chance to make a meaningful impact while growing your regulatory skills at GSK. You will help us unite science, technology and talent to get ahead of disease together. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Prepare and submit regulatory variations and dossier updates through national and European procedures. - Track and follow up regulatory procedures with the national competent authority (INFARMED, I.P). - Maintain and update internal regulatory databases and trackers. - Support updates to product information documents, such as summaries of product characteristics, patient information and labelling. - Review and approve packaging artwork from a regulatory perspective. - Collaborate cross-functionally to deliver strategic Regulatory Affairs activities and business priorities. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals - Degree (Bachelor or Master) in Pharmacy, Pharmaceutical Sciences, Life Sciences or related subject. - Fluent Portuguese and strong English written and spoken skills. - Good organizational skills and ability to manage priorities and deadlines. - Strong attention to detail. - Good communication skills and ability to work in a team. - Dynamic and proactive - Interest in a career in regulatory affairs and readiness to learn. Preferred Qualification If you have the following characteristics, it would be a plus - Postgraduate training or coursework in Regulatory Affairs. - Previous internship or work experience in regulatory affairs or pharmaceutical industry. - Familiarity with national and European regulatory procedures (e.g. national, Mutual recognition Procedure, Decentralized Procedure and Centralized Procedures). - Experience with regulatory databases or document management systems. - Basic understanding of packaging and labelling requirements. - Ability to work independently with initiative and adaptability. Work Arrangement This role is on-site in Portugal with hybrid working options depending on business needs and line manager agreement. What we offer You will receive structured training and coaching. You will work alongside experienced regulatory professionals. You will gain hands-on experience across regulatory processes and exposure to cross-functional projects. This role supports career growth and practical development in an established global company. How to apply We welcome applications from people who are ready to learn and grow. Please apply now with your CV in English and a short note explaining why you want to join regulatory affairs at GSK. We look forward to hearing from you. Skills Agile Planning, Business Acumen, Change Management, Digital Fluency, Learning Agility, Problem Solving, Regulatory Strategies This is a temporary internship opportunity focused on professional development. Any reimbursement, scholarship, allowance, or financial support will be provided in accordance with applicable local laws, regulations, and GSK site policies. More detailed information will be provided during the recruitment process.Esta é uma oportunidade temporária de estágio, com foco no desenvolvimento profissional. Qualquer reembolso, bolsa, subsídio ou outro tipo de apoio financeiro será atribuído de acordo com a legislação local aplicável, bem como com os regulamentos e políticas da GSK no respetivo local. Informações adicionais serão fornecidas durante o processo de recrutamento. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any specific adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on prt-inclusion.recruitment@gsk.com. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. 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/