Submission and Information Specialist

Job description

The Position

We are looking for you to join Roche and our Roche Services & Solutions Center in Budapest. 

Roche is a global healthcare company offering exceptional career paths and great benefits for fresh graduates and outstanding professionals. We are continuously expanding, lookingfor new talents to join our transforming Services & Solutions Center. We offer a flexible working framework (1 office day/week on average) and provide fully remote working conditions within Hungary.

What we do:

We work closely with the Submission Management Group (SMG) in Pharma Technical Regulatory (PTR) as a document and data hub for Quality documents. 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.

Your day to day responsibilities:

• Maintain regulatory documents in regulatory information management systems (RIM), document-management systems (e.g., Documentum) and/or document-sharing systems (e.g., SharePoint)
• Prepare and update technical regulatory documents according to instructions from the PTR product manager or the submission manager and ensure adherence to applicable regulatory (e.g., CTD - Common Technical Document) and Roche CMC - Chemistry, Manufacturing and Control standards, including detailed formatting of documents
• Compile regulatory dossiers, format them for publishing and hand over the dossier for publishing
• Data entry into global regulatory systems, perform trend analysis and generate metrics out of IT Systems
• Collaborate with PTR product managers and with internal partners
• Actively participate in RSS and PTR initiatives.

What can you bring to our team: ​

We are looking for someone who is self-motivated, really passionate about his or her 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:

• 2-5 years of related experience in similar role, with experience in the pharmaceutical industry (minimum BA or BS (or equivalent) degree in biology, chemistry, pharmacy or a related field)
• 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)
• 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)
• An aptitude for teamwork and the ability to interface effectively with PTR submission leads and colleagues located in other countries
• Strong organizational and time-management skills; the ability to deliver under pressure; and the ability to work flexibly to support changing assignments and priorities in an independent and reliable manner
• Ability to work in global teams and openness to change
• Fluent in written and spoken English.

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, and its conditions can be tailored for employees according to needs. We create the opportunity for freedom in working, where your corporate and private life coexist in harmony.

• 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 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

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 1400 employees in Hungary.

Roche is an Equal Opportunity Employer.