Chapter Lead International Regulatory Affairs job opportunity at Roche.

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DatePosted 15 Days Ago bot
Roche Chapter Lead International Regulatory Affairs
Experience: 10-years
Pattern: full-time
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degreeMaster's (M.A.)
loacation Penzberg, Germany
loacation Penzberg....Germany

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 As our new International Regulatory Chapter Lead, you will join the Regulatory Affairs Leadership Team (RLT) to drive global excellence and serve as the key point of contact for our international regulatory capabilities. In this role, you will strategically develop our experts’ technical skills and leadership qualities to meet the needs of a cutting-edge diagnostic portfolio. We offer a culture of growth where you will coach your team through their professional journeys while optimizing the data and processes that shape our global impact. The Opportunity In this pivotal leadership role, you act as a strategic architect for Roche Diagnostics’ international regulatory landscape. Partnering closely with Network Leads, you bridge the gap between long-term vision and operational excellence, ensuring our teams possess the high-caliber expertise required to bring life-saving diagnostic solutions to patients globally. You don't just manage a department; you cultivate an environment where agility, technical mastery, and visionary leadership converge to maintain our position as the world leader in diagnostics. Shape and Implement Strategy: You play a decisive role in crafting and executing Regulatory Affairs’ mid- to long-term strategies, directly influencing the overarching Roche Diagnostics Vision and the success of our Customer Areas. Empower and Develop Talent: You provide active coaching and mentorship to Chapter members across Europe, US, and China, designing personalized professional journeys that foster growth, accountability, and best-in-class expertise. Drive Technical Excellence: You identify short- and long-term capability needs, nurturing a robust pool of Subject Matter Experts (SMEs) who deliver superior regulatory processes and innovative submission strategies. Optimize Resource Allocation: You collaborate with Network Leads to translate strategic direction into resource needs, ensuring the right talent is assigned to the right squads and decision-making bodies to maximize business value. Influence Global Policy: You represent Roche as a senior subject matter expert in front of international regulatory agencies, actively advancing project objectives and shaping policy to improve patient access to diagnostics. Monitor the Regulatory Horizon: You proactively track the global regulatory environment, providing staff and stakeholders with high-level assessments of how changing international laws impact our portfolio and operations. Champion Agile Ways of Working: You foster an agile mindset within the Chapter, promoting the fluidity of resources to ensure our experts can pivot quickly to support different business needs across various networks. Standardize and Innovate Processes: You drive the continuous improvement of data, technology, and best practices, balancing process standardization and asset reuse with the creativity needed for groundbreaking solutions. Who you  are You are a visionary leader and a subject matter expert who thrives on connecting people, ideas, and strategies. You don’t just manage processes; you build environments where talent flourishes and innovation meets compliance. You are a bridge-builder who excels at breaking down silos and navigating complex, evolving landscapes with empathy, objectivity, and a clear sense of purpose. Educational Foundation: You hold a Bachelor’s or Advanced degree in Science or a related field. Regulatory Expertise: You bring 10+ years of experience in Regulatory Affairs within the Diagnostics industry (or a related field), including a deep understanding of global submissions and development strategies for international markets (e.g., China). Proven Leadership: You have a successful track record of managing high-performing teams, and nurturing technical and strategic capabilities within a networked organization. Industry Authority: You possess a history of successful interactions with regulatory bodies and a "thought leadership" mindset regarding international regulatory trends. Global Mindset: You have experience navigating global lifecycles and development processes; additional experience in Affiliate Regulatory Affairs or Quality is a significant plus. A Strategic Coach: You lead with high self-awareness, acting more as a mentor than a traditional manager. You are passionate about defining career paths and inspiring the next generation of regulatory leaders. An Enterprise Thinker: You balance the specific needs of your Chapter with the broader goals of the organization, using your business and financial acumen to make impact-driven decisions. A Collaborative Influencer: You are a master of negotiation and conflict management, able to foster positive partnerships even in high-pressure situations. A Catalyst for Change: You demonstrate the courage and drive to stay at the forefront of industry trends, ensuring we maintain our #1 ranking through transformative solutions. Locations You can be based in Mannheim, Penzberg, Rotkreuz, Sant Cugat, Santa Clara, Tucson, Basel, Branchburg, Indianapolis or Pleasanton. At the Company's discretion, an exception to the location requirement could be made under extraordinary circumstances.   As this position is a global role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities. Application documents To make the application process as convenient as possible for you please add only your updated CV . References and certificates are not required at this stage. Application period until at least March 5th 2026. We look forward to receiving your application.     Dort, wo Entgelttransparenz vorgeschrieben ist, geben wir die Informationen basierend auf dem Hauptstandort der Stelle an. Für diese Position ist der Hauptstandort Penzberg. Falls Du dich für einen anderen Standort interessierst, an denen die Stelle möglicherweise ebenfalls verfügbar ist, geben wir Dir die entsprechenden Entgeltinformationen im weiteren Verlauf des Bewerbungsprozesses. Your contact to us! With people. For people. Do you need further support? Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq . 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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