Regulatory Labelling Associate (fixed-term)

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The 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 is a fixed term position with a duration of 18 months.

Who you are:

• 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

• You possess a basic knowledge of scientific- and regulatory labeling environment and procedures

In exchange, we provide you with:

• Development opportunities: Roche is rich in learning resources.We provide constant development opportunities, free language courses & trainings, the possibility of international assignments, internal position changes and the chance to shape your own career.

• Excellent benefits & flexibility: 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. We also ensure flexibility, to help you find your balance: home office is a common practice (2 office days/week, and we provide fully remote working conditions within Hungary).

• A global diverse 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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Roche Services & Solutions as well as People Support Solutions organisations located in Budapest provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the EMEA region. Today Roche employs altogether around 2000 employees in Hungary.

Roche is an Equal Opportunity Employer.