Global Regulatory Chapter Lead
Roche
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. 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. 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, U.S., 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, 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 on the business location of the successful candidate and ongoing business project activities. 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. Roche is an Equal Opportunity Employer. #J-18808-Ljbffr
$148.7k - $297.3k
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$32.25 - $49.35 per hour
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$61.3k - $122.7k
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$249.8k - $374.8k
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