Regulatory Submission Lead

GlaxoSmithKline; Poznań; Hybrid; PLN 132,000 - 220,000; Full time

Benefits offered by this job

Medical Plan

Life Insurance

Employee Retirement Program

Sport and recreation cards

Recreation allowance

Annual bonus

Job summary

GlaxoSmithKline in Poland is seeking a Regulatory Submission Lead to plan, compile and deliver high-quality dossiers for lifecycle activities. You will coordinate inputs from clinical, CMC, quality and regulatory teams, ensuring timely submissions and audit readiness.

The role emphasizes global collaboration, strong English communication and process improvements, with a hybrid work arrangement combining on-site and remote days. Growth opportunities are highlighted in a world-class pharma setting.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline.

Responsibilities

• Plan, compile and deliver high-quality electronic and paper regulatory dossiers within agreed timelines.
• Coordinate cross-functional inputs from clinical, CMC, quality, safety and commercial colleagues to complete submissions.
• Build, validate and quality-check electronic submission packages and resolve technical validation issues.
• Maintain submission trackers, version control and milestone plans to ensure transparency and audit readiness.
• Prepare responses to regulatory authority questions and support regulatory meetings when required.
• Identify and implement process improvements, coach colleagues and share best practice.

Skills

Regulatory strategies

Agile planning

Business acumen

Change management

Digital fluency

Learning agility

Problem solving

Education

Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline

Tools

Veeva Vault

Job description

You will lead planning, compilation and delivery of regulatory submission dossiers for lifecycle activities. You will coordinate with global submission teams, clinical, CMC (Chemistry, Manufacturing and Controls), quality, publishing and local regulatory partners. We value organised, collaborative people who communicate clearly and focus on practical solutions. This role offers visible impact on patient access, clear growth opportunities, and aligns with GSK’s 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:- Plan, compile and deliver high-quality electronic and paper regulatory dossiers within agreed timelines.- Coordinate cross-functional inputs from clinical, CMC, quality, safety and commercial colleagues to complete submissions.- Build, validate and quality-check electronic submission packages and resolve technical validation issues.- Maintain submission trackers, version control and milestone plans to ensure transparency and audit readiness.- Prepare responses to regulatory authority questions and support regulatory meetings when required.- Identify and implement process improvements, coach colleagues and share best practice.Why You?Work arrangementThis role is hybrid. You will work on-site 2–3 days per week and remotely for the remaining days, as agreed with your manager.Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:-Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or a related discipline, or equivalent experience.- Minimum 3 years’ experience in regulatory affairs, submission management, publishing or lifecycle maintenance in the pharmaceutical or clinical research environment.- Practical experience compiling regulatory dossiers and managing submission timelines for investigational or marketed activities.- Experience preparing electronic submissions and familiarity with eCTD principles or equivalent electronic submission practices.- Strong written and verbal communication skills in English; able to present clear updates to stakeholders.- Strong organisational skills, attention to detail and ability to manage competing priorities under deadlines.Preferred QualificationIf you have the following characteristics, it would be a plus:- Experience with regulatory content or information management systems such as Veeva Vault or similar platforms.- Experience with CMC content, Module 1 preparation or local language submission requirements.- Experience supporting regulatory authority interactions and preparing authority responses.- Practical knowledge of market regulatory requirements.- Experience working in a global, matrix environment and coordinating third-party service providers.- Acting as single point of contact for submissions.What we value in youYou make evidence-based decisions and raise issues early. You balance pace with rigour and focus on quality. You build strong working relationships and share learning. You bring a growth mindset and a willingness to coach others. You will help improve patient access through regulatory excellence.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!Ready to apply?If this role feels like the next step, we encourage you to apply. We welcome applicants from all backgrounds and support inclusion. Please tell us how you would like to grow and how your skills will support important regulatory work. If you need adjustments during recruitment, let us know and we will support you.#LI-GSK#LI-HYBRIDSkillsAgile Planning, Business Acumen, Change Management, Digital Fluency, Learning Agility, Problem Solving, Regulatory StrategiesPolish Salary Range / Polski przedział wynagrodzenia: PLN 132,000 to PLN 220,000The 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 [e-mail] 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/ 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/