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Regulatory Labelling Associate (Maternity cover)

roche
Companyroche
CategoryLegal & Compliance
LocationBudapest
RemoteOn-site (inferred)
EmploymentNot stated
LevelNot stated
SalaryNot stated by the employer
Posted25 Jul 2026
Last verified11 Aug 2026
SourceEmployer ATS (workday)
Applications are handled by the employer, not by us.Apply on the employer's site →
Description
Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt. Die Position What we do: Global Labeling (PDRL) ensures the consistent and safe use of our medicines through high-quality labels to create and maintain scientifically-sound, evidence-based, and balanced labels. The Labeling function leads the development and update of core datasheet (CDS), EU Summary of Product Characteristics (SmPC) and US Product Information (USPI) in partnership with Regulatory Program Management and cross-functional experts throughout the lifecycle. In addition, a Labeling compliance unit tracks CDS implementation into local product Information and ensures end-to-end labeling oversight and adherence to regulatory standards. The opportunity: • Support and assist PDRL colleagues to accomplish tasks in meeting deadlines to achieve the project, team and departmental goals • Under supervised coaching and tutoring, gradually assume responsibility for agreed tasks • Prepare regulatory labeling packages in collaboration with the other teams • Participate in and support the development and implementation of the regulatory labeling strategies • Support, as requested, Labeling colleagues and Regulatory lead in the implementation of CDS changes into local products labels and the management of local label deviations • Support the PDRL system and compliance activities as requested • Acquire and maintain an overview of relevant regulatory labeling requirements, develop the potential to demonstrate the core competencies required for a senior regulatory labeling associate Please note that this position is a fixed-term maternity cover. Who you are: • You possess a knowledge of scientific- and regulatory labeling environment and procedures • You have a university degree, preferably in a scientific / technical discipline • You have a basic working knowledge of drug discovery, development, manufacturing and marketing • You are fluent in written and spoken English • You are able to provide input, set milestones, and monitor progress towards results within sub-teams to achieve team goals In exchange we provide you with: • Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & training, the possibility of international assignments, internal position changes and the chance to shape your own career. • Excellent benefits: Competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. • Flexibility: We also support flexibility to help you find your balance. Home office is commonly available (typically 2 office days/week on average). • A global inclusive community , where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion. Please read the Data Privacy Notice for further information about how we handle your personal data related to the recruitment process: https://go.roche.com/budapest-data-privacy-notice-candidate Wer wir sind Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern. Gemeinsam können wir eine gesündere Zukunft gestalten. Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.