Regulatory Program Manager

Job title:

Regulatory Program Manager

Company:

Roche

Job description

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 PositionWe work closely with the Submission Management Group (SMG) in Pharma Technical Regulatory (PTR) as a document and data hub for Quality documents.The opportunity: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 documentsCompile regulatory dossiers, format them for publishing and hand over the dossier for publishingData entry into global regulatory systems, perform trend analysis and generate metrics out of IT SystemsCollaborate with PTR product managers and with internal partnersActively participate in RSS and PTR initiatives.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: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 countriesStrong 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 mannerFluent 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 (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 read the Data Privacy Notice for further information about how we handle your personal data related to the recruitment process:Who we areAt 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.

Expected salary

Location

Budapest

Job date

Fri, 08 Nov 2024 23:59:03 GMT

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