Regulatory Affairs Executive

Posted Yesterday
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Grunwaldzkie, Olsztyn, Województwo warmińsko-mazurskie, POL
In-Office
132K-220K Annually
Mid level
Healthtech • Biotech • Pharmaceutical
The Role
Lead and coordinate regulatory activities and marketing authorisations across assigned markets. Manage submissions, product information and labelling compliance, regulatory documentation, agency correspondence, and third‑party partners. Provide regulatory guidance, monitor regulatory changes, support compliance frameworks, and ensure continuity of supply and quality across matrix stakeholders.
Summary Generated by Built In

As a Regulatory Executive you will provide operational regulatory leadership and coordination across assigned markets, working closely with regional teams, content delivery partners and third‑party service providers. You will play a critical role in ensuring regulatory processes are delivered with quality, compliance and continuity of supply, in line with applicable regulations and governance frameworks.

Key responsibilities

In this role, you will:

  • Manage marketing authorisations and regulatory activities for assigned markets, acting as the primary interface with internal partners and external service providers.

  • Plan, track and coordinate regulatory submissions and commitments, ensuring alignment with agreed strategies, timelines and regulatory requirements.

  • Ensure product information and labelling remain compliant with regulatory approvals and local requirements, including coordination of local language translations where applicable.

  • Coordinate the management of regulatory documentation, agency correspondence and records within approved systems and repositories.

  • Build strong, collaborative relationships with cross‑functional stakeholders, providing clear regulatory guidance and operational insight.

  • Oversee and collaborate with regulatory third‑party partners, ensuring delivery against objectives, KPIs and compliance standards.

  • Support compliance with internal regulatory control frameworks, including KPIs, risk and issue management, audits, assessments and training.

  • Monitor changes in the regulatory environment and provide regulatory intelligence on potential impacts to relevant stakeholders.

Why you?

Basic qualifications

We are looking for professionals with:

  • A degree (or equivalent) in a scientific discipline such as Life Sciences or Pharmacy.

  • Minimum 4 years’ experience in Regulatory Affairs within a complex, regulated environment.

  • Experience working across multiple markets and matrix organisations.

  • Strong understanding of regulatory policies, processes and governance frameworks.

  • Fluent English (written and spoken)

Preferred capabilities

  • Experience working with regulatory third‑party service providers.

  • Experience working with CIS Eurasian Economic Union Regulatory procedures.

  • Strong project management skills and the ability to manage multiple priorities in a fast‑paced environment.

  • Russian ( written and spoken)

  • Confidence working with cross‑functional stakeholders and influencing outcomes with sound judgement.

  • A proactive, forward‑thinking approach to identifying regulatory risks and opportunities.

Why GSK?

At GSK, we are driven by a clear purpose: to unite science, technology and talent to get ahead of disease together.

We offer:

  • Meaningful work with real impact on patients

  • A culture that values inclusion, integrity and accountability

  • Flexible ways of working to support your wellbeing

  • Hybrid working model and flexibility in line with LOC policy.

  • Competitive compensation and benefits package aligned with local market practices.

  • Continuous learning and development opportunities within a global organisation.

#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 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 [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/

Skills Required

  • Degree in a scientific discipline (Life Sciences or Pharmacy)
  • Minimum 4 years' experience in Regulatory Affairs within a complex, regulated environment
  • Experience working across multiple markets and matrix organisations
  • Strong understanding of regulatory policies, processes and governance frameworks
  • Fluent English (written and spoken)
  • Experience working with regulatory third‑party service providers
  • Experience with CIS Eurasian Economic Union regulatory procedures
  • Strong project management skills and ability to manage multiple priorities
  • Russian (written and spoken)
  • Confidence working with cross‑functional stakeholders and influencing outcomes
  • Proactive approach to identifying regulatory risks and opportunities

GSK Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GSK and has not been reviewed or approved by GSK.

  • Strong & Reliable Incentives Compensation is characterized as including strong salary and perks, with annual bonuses and long-term incentives contributing materially to total rewards. Recognition and performance-linked rewards are described as a consistent component of the package.
  • Healthcare Strength Health coverage is presented as comprehensive, spanning medical, dental, vision, disability, life insurance, and mental health benefits. The breadth of coverage is repeatedly framed as a standout element of the overall rewards experience.
  • Retirement Support Retirement offerings are described as robust, anchored by a 401(k) plan and additional savings vehicles such as employee stock purchase programs. Employer contributions and savings options are portrayed as meaningful supports for long-term financial security.

GSK Insights

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The Company
HQ: Brentford
105,615 Employees
Year Founded: 2000

What We Do

A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.

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