Regulatory Affairs Manager

Company: F. Hoffmann-La Roche Gruppe
Location: Santa Clara
Posted on: November 8, 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.At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in systems and software. This role will specifically support our Digital Pathology portfolio in our Pathology Lab Customer Area. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.The Opportunity

• You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs. You develop and manage parts of comprehensive global regulatory submissions and registration plans.
• You interface with external management. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders. You build effective and enduring external relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up.
• You lead the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. You have the 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. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
• You effectively partner with stakeholders to understand and provide best solutions. You take initiative to address problems or opportunities and involve collaborators for best solutions. You develop relationships that significantly influence the current and future direction for Roche and our products.
• You have courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently. You embrace good decision making principles.
• You model VAAC Leadership and agility. You identify opportunities to develop VACC competency. You act with integrity, courage, passion and honor commitments and contribute to an inclusive environment which supports all dimensions of diversity.
• You are able to pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes. You address and resolve conflict by creating an atmosphere of openness and trust. You bring out the best in people and teams.Who you are
  • You have a Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
  • You have 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.
  • You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
  • You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
  • You have demonstrated the ability to manage more complex work and/or at parts of global projects.LocationsYou are local to Santa Clara, Branchburg, Indianapolis, Pleasanton or Tucson. You must be local to a US Diagnostics site.*Relocation assistance is not available for this position.*The expected salary range for this position based on the primary location of Santa Clara is $118,000-$219,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.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.Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form .
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