Reg Submission Specialist, SDE - Investigational

Descrizione del lavoro:

You will manage end-to-end regulatory submissions for investigational products, working with global regulatory teams, clinical operations, and technical experts. You will plan, prepare and submit clinical trial applications (CTAs) and related documents across multiple regions, ensuring timelines and regulatory requirements are met. We value clear communicators who are organised, collaborative and curious. This role offers growth, meaningful impact and the chance to help GSK unite 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, compile and submit clinical trial and investigational submissions (e.g., EU CTR/IND/IND) according to country requirements.
* Coordinate cross-functional input from clinical, quality, CMC, safety and legal teams to ensure submission content is complete and accurate.
* Manage submission timelines, trackers and regulatory systems to ensure on-time delivery.
* Respond to regulatory authority queries and support follow-up activities until decisions are reached.
* Maintain submission records and ensure compliance with GSK processes, policies and good documentation practices.
* Identify opportunities to simplify submission processes and support team improvements and digital tools.

Responsibilities
You will work day-to-day with global and local regulatory colleagues, clinical teams and external partners. You will take ownership of end-to-end submission tasks and help drive quality and consistency across processes. You will be expected to act with integrity, attention to detail and a focus on timely delivery.

Why You?
This role is based in Poland and is offered as a hybrid role. You will be expected to attend the office regularly as agreed with your manager.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
* Degree in life sciences, pharmacy, chemistry, or a related scientific discipline.
* At least 2 years of experience in regulatory submissions, clinical trial applications, or an equivalent role in the pharmaceutical or biotech industry.
* Practical knowledge of clinical trial submission requirements and local regulations.
* Strong written and verbal English communication skills.
* Proven ability to manage multiple tasks and meet tight deadlines.
* Good collaborator with experience working in cross-functional or matrix teams.

Preferred Qualification
If you have the following characteristics, it would be a plus:
* Experience with electronic submission formats and regulatory submission systems.
* Familiarity with CTD/eCTD structure and content or other submission standards.
* Exposure to global submission requirements across US, EU, UK and other international markets.
* Experience responding to regulatory authority questions and managing post-submission activities.
* Good understanding of clinical development processes and trial documentation.
* Project management skills or formal training in project coordination.

At GSK we offer a wide range of additional benefits:
* Career at one of the leading global healthcare companies
* Hybrid work (2 days per week from the office)
* Contract of employment
* Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
* Life insurance and pension plan
* Private medical package with additional preventive healthcare services for employees and their eligible counterparts
* Sports card
* Possibilities of development within the role and company's structure
* Personalized learning approach
* Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
* Supportive community and integration events

#LI-GSK
#LI-HYBRIDPolish Salary Range / Polski przedział wynagrodzenia: PLN 97,500 to PLN 162,500The 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 pl.recruitment-adjustments@gsk.com 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