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 niektórych rynkach obowiązują przepisy dotyczące jawności wynagrodzeń, które wymagają zamieszczania takich informacji w ogłoszeniach o pracę, a wskazane lokalizacje mogą stanowić potencjalne miejsce wykonywania tej roli. Jeśli przedział wynagrodzenia nie jest podany w ogłoszeniu dla konkretnej lokalizacji lub kraju, odpowiednie informacje o wynagrodzeniu zostaną omówione w trakcie procesu rekrutacyjnego. Prosimy pamiętać, że poziom wynagrodzenia różni się w zależności od kraju i jest ustalany na podstawie umiejętności, doświadczenia, poziomu wykształcenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty są zazwyczaj przedstawiane w granicach wskazanego przedziału, z uwzględnieniem umiejętności, doświadczenia i kwalifikacji kandydata, przy czym górna granica jest zwykle zarezerwowana dla kandydatów o bardzo dużym doświadczeniu lub w innych wyjątkowych okolicznościach zgodnych z tymi kryteriami.

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.

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.

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/