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.

What we do:

The Regulatory Operations Group is part of the broader Product Development  Regulatory (PDR) organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers, and prescribers for Roche’s global Pharma Medicines Division. PDR is responsible for the timely submission of applications to health authorities. We also work closely with the Submission Management Group (SMG) in Pharma Technical Regulatory (PTR) as a document and data hub for Quality documents.
The Clinical Trial Regulatory Management Team enables the development of organizational and people capabilities of the future, we support and optimize the delivery of projects and initiatives to the organization both on the molecule and molecule-enabling portfolio.
Global Labeling 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 opportunity:

We provide coordination, compilation, publishing, and submissions expertise in the preparation of new and existing regulatory applications. We ensure technical documentation support by preparation and formatting of regulatory documents; maintenance of regulatory documents in the document management system; compilation of submission dossiers, hand-over to publishing. Ensure regulatory information in systems is accurate, complete and relevant to the different needs of our stakeholders.

We are looking for talented and highly motivated individuals who will shape the future of this challenging function. Our team is diverse with members of different educational backgrounds and various levels of experience. As a qualified expert, you:

Gain exceptional professional knowledge about Regulatory Submission, Clinical Trial and related Regulatory Operation areas to support our teams 

Help to build a knowledge base and leverage best practices in the area of Regulatory Submissions, Clinical Trials and supporting activities

Develop your mentoring skills by training new joiners or other team members

Continuously improve process efficiency and support service quality exercises

Build a wide network within the operation groups to ensuring smooth operations in different teams

Who you are:

We are looking for someone who is self-motivated, really passionate about their job and understands that providing a high-quality service is crucial for the organization. As an ideal team member you are open-minded, dedicated to make a difference and open to constant development. Furthermore, you have:

1-3 years of related experience in a similar role, preferably with a life sciences degree and/or data/system related degree.

Proficiency in a broad range of IT skills, including expert-level use of Word, Excel and Acrobat and experience with document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint)

Maintain and manage regulatory documents and data in regulatory information management systems (e.g RIM, Documentum) and/or document-sharing systems (e.g., SharePoint)

Tenacious attention to detail and consistency, especially with respect to data, style, format, and layout and ability to format technical documents using electronic tools (e.g., Acrobat)

The skills for collaboration and the ability to interface effectively with submission leads and colleagues located in other countries. 

Ability to work in fast-paced global teams

Fluent in written and spoken English

Logical thinking and/or process analyst mentality

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, language allowance (if the position requires extra language),  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.

Please note, that this is a requisition for Talent Pool building purposes, which means it may not necessarily reflect a current opening with ongoing recruitment or selection process, but a position we are frequently recruiting for or we are planning to open in the near future.

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

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.

Roche is an Equal Opportunity Employer.