In this role You will support regulatory operations for the Gödöllő site, ensuring compliance with local and global requirements. You will manage regulatory documentation, submissions, and change control processes, working closely with colleagues across the site and global teams.
We value detail-oriented professionals who can communicate clearly, organize complex tasks, and build strong collaborative relationships.

Responsibilities:

• Participation in the preparation of variations, regulatory submissions, and file renewals (CMC Module 3 sections)

• Create regulatory source documents for file preparation including MoA, MoP, Core File etc.

• Preparation of technical documents (Site Master File and Core File) related to the Manufacturing License (ML) of the Site

• Arrange legalization of GMP and ML certificates for the regulatory submissions

• Collecting all necessary information from relevant departments and answer questions of authorities related to file/variation submissions

• Formulate responses to questions from Health Authorities

• Act as liaison between the site and global teams on regulatory compliance matters

• Provide site input to GRA for the definition and execution of the submission strategy

• Acts as liaison between the Hungarian regulatory agency and GSK Gödöllő

• Participation in Change Control processes

• Deliver regulatory advice to assess the potential regulatory impact of changes proposed by the site

• Perform source document assessment for regulatory impact change controls (also involved to the review of source documents)

• Preparation and update of SOPs

• Perform trainings of personnel

Basic Qualifications & Skills:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Master’s degree in life sciences, pharmacy, chemistry, engineering, or a related field.

• Experience in regulatory affairs or related roles is an advantage, but recent graduates are welcome to apply.

• Interest or practical exposure to regulatory file maintenance, license management, or dossier support.

• Ability to plan tasks, track progress, and deliver on timelines.

• Proficiency in MS Office; familiarity with regulatory or document management systems (e.g., Veeva) is a plus.

• Fluent English and Hungarian required.

Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:

• Experience working in a pharmaceutical manufacturing or GMP environment.

• Experience with Veeva Vault, SAP or similar systems.

• Experience working in a matrixed, global organisation.

• Strong stakeholder engagement and clear written communication skills.

• Practical problem solving with a focus on improving efficiency and data quality.

What we offer:

• Hybrid working with flexible working hours

• Indefinite contract

• Annual bonus & annual pay review

• Cafeteria

• Inclusive & supportive environment

• Life and accident insurance package

• Voluntary pension fund contribution

• Shuttle buses to the site from Budapest and nearby towns or fuel support if you own a car

#LI-Hybrid

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.

Should you require any specific adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected].

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels’.

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.

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