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You will prepare, publish, and submit regulatory document packages to Health Authorities while ensuring compliance with technical standards. Additionally, you will collaborate with internal teams and IT to manage regulatory records, support system administration, and drive process improvements.
Candidates must hold a bachelor's degree in life sciences, pharmacy, chemistry, or information management, along with 1–3 years of experience in regulatory affairs. Proficiency in MS Word, PDF tools, and document repository platforms is required, alongside fluent English and good Polish language skills.
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.
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
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 pl.recruitment-adjustments@gsk.com to discuss your needs.
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.
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/
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
Offices: 79 New Oxford Street, London, England WC1A 1DG, GB · 5 Crescent Drive, Philadelphia, Pennsylvania PA 19112, US · Gunnels Wood Road, Stevenage, England SG1 2, GB · 9 Canton Rd, 23/F, Tower 6, The Gateway, Kowloon, Hong Kong ., HK · Bogota Corporate Center Av. Eldorado No. 69B – 45 / 9th Floor Bogotá, D.C., Bogota, Bogota, D.C. 110931, CO
There are currently 85 open healthcare positions in Poznan, Poland listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Roche, GSK, Haleon, bloom Hörakustik, Medtronic, among others. Browse the listings above to see every active employer.
Yes — 67 of the 85 open healthcare positions offer remote or hybrid work (5 remote, 62 hybrid).
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