Regulatory Program Specialist job opportunity at Roche.

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DateMore Than 30 Days Ago bot
Roche Regulatory Program Specialist
Experience: General
Pattern: full-time
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loacation Budapest, Hungary
loacation Budapest....Hungary

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 The opportunity: Are you a regulatory professional ready to innovate, collaborate, and create impactful outcomes? Join us as a Regulatory Program Specialist in the Pharma Technical Regulatory Submission Management Group. In this role, you will play a pivotal part in global planning, tracking, and monitoring of regulatory information crucial for compliance and successful submission execution. You will : Manage regulatory information activities in coordination with the regulatory product portfolio team. Partner with various departments to ensure seamless submission processes. Oversee the editing and formatting of technical documents. Coordinate document flow within the management system and ensure version control throughout the submission process. Ensure timely delivery of content and maintain clear communication with technical subject-matter experts. Who you are: 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: Proficiency in a broad range of IT skills, including expert-level use of Word, Excel and Acrobat and experience with document-management systems and document-sharing systems (proficiency in Veeva Vault RIM preferred) 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 Fluent in written and spoken English 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 is an advantage) 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. Data Privacy Notice for further information about how we handle your personal data related to the recruitment process: https://go.roche.com/dpn4candidates     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.

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