Regulatory Affairs Specialist

Company: F. Hoffmann-La Roche Gruppe
Location: San Jose
Posted on: October 4, 2024

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 PositionA healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.As Regulatory Affairs Specialist, you are part of a global RIM (Regulatory Information Management) Support HUB. The HUB will mainly support Affiliates by working closely with PDR (Pharma Development Regulatory), PTR (Pharma Technical Regulatory) and DRA (Affiliate Drug Regulatory Affairs) worldwide. This is a great chance to support a new technology implementation in the affiliates; you will connect with teams across the world and enable Roche to streamline and optimize the way we work with the Veeva RIM system.Your OpportunityThe responsibilities for this role include:

• Responsible for affiliate activities in the RIM System for specific countries without access, in cooperation with the affiliates and the global teams. This includes tracking, publishing, archiving.
• General support and troubleshooting of day-to-day activities for affiliates worldwide, including bundling of submissions, data fixes, managing Technical Regulatory submissions and preparation of the Submission Content Plans.
• Involved in training and onboarding of Agents in specific countries in cooperation with the affiliate and global teams.
• Collaboration and partnering with affiliate network / affiliate PDR and other functions to understand and improve Business Processes and learning needs.
• May be involved in the development and updating of guidance documents and job aids and provide training for affiliates. Providing input on future system enhancements and business process updates.Who you areThe person in this role has knowledge and curiosity about new concepts and technology. Ability to learn quickly and adapt to changes. Good communication skills and ability to simplify and teach others, has the ability to collaborate and work virtually with a variety of people across time zones, hierarchies and cultures, is able to build and maintain productive and trusted relationships within the organization and our external partners.
• University studies in a related field.
• Experience working in the regulatory affairs area, in similar roles with an understanding of the regulatory framework.
• Experience with Veeva RIM is a nice to have.
• Advanced English proficiency is required.
• Follows regulations and company policies, and complies with all Business Processes.
• Demonstrates a continuous improvement mindset.Relocation benefits are not available for this job posting.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 San Jose provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the Americas region. Today Roche employs altogether around 800 employees in Costa Rica.Roche is an Equal Opportunity Employer.
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Keywords: F. Hoffmann-La Roche Gruppe, Merced , Regulatory Affairs Specialist, Other , San Jose, California