Reg Submission Specialist, SDE - LCM

You will join the Lifecycle Management team in Poland to support regulatory submissions and maintenance activities. You will prepare, publish and track submission documents while working with authors, regulatory colleagues, IT and supply partners. We value clear communicators who deliver high quality work, learn quickly and help improve systems. This role offers visible impact, practical growth in regulatory affairs, and a chance to contribute to our mission of uniting science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Prepare, assemble, publish and submit document packages to Health Authorities, that meet regulatory technical standards and GSK requirements. Coordinate document collection and preparation activities in collaboration with sites, suppliers and internal teams. Validate published packages, resolve technical validation errors and work with authors to correct source document issues. Maintain and quality-check regulatory records in submission and information systems and support routine data extracts and reporting. Support system administration, user training and user acceptance testing for internal tools such as Regulatory Vault. Identify risks, drive issue resolution with stakeholders and escalate appropriately to protect delivery and compliance. Responsibilities: Deliver end-to-end preparation and submission of dossiers to agreed timelines and technical specifications. Review submissions for completeness and format; log gaps and follow up to ensure timely resolution. Use Regulatory Vault to ensure documents are fit for submission. Produce clear status updates and reports for submission teams and management. Collaborate with IT and business system owners to support system changes, testing and user support. Contribute to process improvements, standard work instructions and team knowledge sharing. Why You? Working arrangement This role is hybrid. You will work regularly from our office in Poland and collaborate with international colleagues. Exact hybrid pattern will be agreed with your manager. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor’s degree in life sciences, pharmacy, chemistry, information management or related field. Minimum 1–3 years’ experience in regulatory affairs. Practical experience preparing and formatting documents using MS Word and PDF tools. Experience using document repositories or collaboration platforms such as SharePoint. Strong attention to detail, organizational skills and the ability to meet tight deadlines. Fluent English for written and verbal communication; good Polish language skills. Preferred Qualification If you have the following characteristics, it would be a plus: Experience with regulatory content management systems such as Veeva Vault or similar platforms. Exposure to eCTD or non-eCTD processing workflows and electronic submission structures. Experience supporting user acceptance testing or basic system administration for regulatory tools. Previous work in a regulated pharmaceutical or clinical development environment. Knowledge of regulatory processes and lifecycle maintenance activities. Additional training or certification in regulatory affairs, document control, or information management. What we offer: Established job in an international, well-known pharmaceutical company. Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets. Opportunity to work within GSK standards and documentation applied globally. Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus). Supportive & friendly working environment. We’re looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference. If this sounds like you, we’d love to hear from you! #LI-GSK #LI-HYBRID Skills Agile Planning, Business Acumen, Change Management, Digital Fluency, Learning Agility, Problem Solving, Regulatory Strategies Polish Salary Range / Polski przedział wynagrodzenia: PLN 89,250 to PLN 148,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Roczny przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniają szereg czynników, w tym umiejętności kandydata, doświadczenie, poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiązujących polityk wewnętrznych, rola ta może również uprawniać do otrzymania premii (jeśli ma zastosowanie i jest przyznawana na podstawie określonych, obiektywnych kryteriów) oraz/lub nagród za wyjątkowe wyniki (przyznawanych według uznania pracodawcy). Wszystkie świadczenia ustawowe będą zapewnione zgodnie z przepisami prawa polskiego. Mogą być także oferowane dodatkowe benefity, takie jak prywatna opieka medyczna, dodatkowe płatne dni wolne, ubezpieczenie na życie, prywatny plan emerytalny oraz w pełni płatny urlop rodzicielski i urlop na opiekę nad członkiem rodziny. Bardziej szczegółowe informacje na temat całkowitego pakietu wynagrodzenia i świadczeń przypisanego do tego stanowiska zostaną przekazane podczas procesu rekrutacyjnego. Przedziały wynagrodzenia dla innych krajów mogą być również widoczne, ponieważ na niektór