Regulatory Labelling Associate (Maternity cover)

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. 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 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

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.