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 Position Fusion - Regulatory Affairs Manager Main Tasks of the role: * Products for the respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions. * The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines. * The obtained Regulatory approvals/licences products are maintained throughout the life cycle of the product by applying successful Regulatory change controls. * The efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc). * The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are are transparent within the organization. * The activities are driven by a mindset of innovation, agility and the principles of VAAC leadership. 1. Regulatory document and submission compilation: Oversees the development of submission/product registration dossiers of more complexx products/programs. Develops and manages at least parts of comphrehensive global regulatory submissions and registration plans. May act as mentor for more junior team members in this area. 2. External interface management: Understands the structure, key roles and responsibilities of external customers/stakeholders. Understands and communicates timely and effectively the needs of external customers/stakeholders. Builds effective and enduring external relationships and applies effective stakeholder management practices. Actively contributes to audits by supporting preparation, execution and follow up. 3. Regulatory knowledge and strategy: Leads the organization to adapt to evolving regulatory environment and requirements. Experience in solving complex, critical health authority issues or equivalent Understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. Ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidence. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals. 4. Stakeholder management and influencing: Effectively partners with stakeholders to understand and provide best solutions.Takes initiative to address problems or opportunities and involves stakeholders for best solutions. Develops relationships that significantly influence the current and future direction for Roche and our products. Understands what motivates other people to perform at their best. Is skilled at managing and influencing peers. Fosters an exchange of ideas amongst key stakeholders to be able to shift perspectives to reach a common agreeable outcome.Negotiates with stakeholders and creates win-win compromises 5. Decision making: Has courage to make decisions even outside of scope/comfort zone. Proactively Initiates activities independently and initiates interactions across departments as applicable.Embrace the good decision making principles. Pushes decision making to the lowest appropriate level. Commits to decisions that have been made.Shows good judgment in decision making.Makes good decisions without necessarily having all the information in a timely manner. 6. Innovation and problem solving: Drives innovation across the organization/sites. Advocates for and helps progress new ideas that add business value. Sees the value in others' unique differences.Is entrepreneurial; seizes new opportunities.Works to drive new ideas into the business. Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance. Identifies problems before they occur and actively drives mitigation strategies to avoid them. Leads others in problem-solving acitivites. 7. VAAC Leadership and agility: Starts to live the spirit of we all lead. Identifies opportunities to develop VACC compentency. Acts with integrity, courage, passion and honors commitments. Contributes an inclusive environment which supports all dimensions of diversity. Explores the opportunity of leadership and future contribution. Takes initiative when opportunities arise. Change ambassador for their environment. Actively develops their agile mindsets and behaviours and encourages others to do so as well. Identifies and acts on opportunities for improvement within across Q&R. Embraces new technologies and other means to simplify and increase productivity. 8. Teamwork and communication: Is able to pull people together around a common goal. Seeks to understand and build on different perspectives to enhance outcomes. Addresses and resolves conflict by creating an atmosphere of openness and trust. Brings out the best in people and teams. Makes people feel that they are truly heard. Expresses complex ideas fluently and clearly.Encourages direct and open discussions about important issues. Can be depended on to tell the truth regardless of the circumstances.Recognizes and reflects/articulates multiple points of view on an issue. Provides honest input even in difficult situations.Speaks up and actively participate. Creates an environment of recognition and appreciation. Requirements * Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience or equivalent * Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices. * 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. * Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage * Has demonstrated the ability to manage more complex work and/or at least parts of global projects. Some business travel may be required 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. Roche Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2'700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here. Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events. We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer.