Regulatory Affairs Manager

Job description

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 Job Summary: 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/licenses 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 transparent within the organization. Main Tasks & Responsibilities: 1. Regulatory document and submission compilation: Oversees the development of submission/product registration dossiers of more complex products/programs. Develops and manages at least parts of comprehensive 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 guidance. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide 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 activities. Requirements Bachelor’s degree in Life Science, Data Science or related subject or equivalent experience or equivalent qualification for the tasks and has worked with many years of experience. Advanced degree is considered an advantage Preferred: Master degree in Life Science, Data Science or related subject or equivalent experience or equivalent qualification for the tasks and has worked with many years of experience. Advanced degree is considered an advantage Fluent English 6-8 years with Bachelor degree or 5-7 years with Master’s degree in the field of IVDs/Medical devices with significant experiences in Regulatory Affairs or equivalent Preferred: 8-10 years with Bachelor degree or 6-8 years with Master’s degree in the field of IVDs/Medical devices with significant experiences in Regulatory Affairs or equivalent Expertise Knowledge of the China 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 Preferred: Expertise Knowledge of the China, EU and US 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 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.