F. Hoffmann-La Roche AG
Companion Diagnostics Regulatory Affairs Manager
F. Hoffmann-La Roche AG, Santa Clara, California, us, 95053
Companion Diagnostics Regulatory Affairs Manager
Apply locations Tucson, Santa Clara, Branchburg, Carlsbad, PleasantonTime type: Full timePosted on: Posted 2 Days AgoJob requisition id: 202411-129892Roche 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
A 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 companion diagnostics in International markets (i.e. all markets except US and EU). This role will specifically support our companion diagnostics 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 countries.The OpportunityYou oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of complex products/programs in International markets. You develop and manage parts of comprehensive global regulatory submissions and registration plans.
You interface with external stakeholders (such as pharma partners) and understand the structure, key roles, and responsibilities of external customers/stakeholders. You communicate timely and effectively the needs of external customers/stakeholders, building effective and enduring external relationships and applying effective stakeholder management practices.
You lead the organization to adapt to the evolving regulatory environment and requirements, interpreting and applying understanding of the regulators' thinking to projects and applying 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 the courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently, embracing good decision-making principles.
You model VAAC Leadership and agility, identifying opportunities to develop VACC competency. You act with integrity, courage, passion, and honor commitments while contributing to an inclusive environment that 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, bringing out the best in people and teams.
Who you areYou have a Bachelor’s/Master's degree in Life Science, Data Science, or related subject or equivalent experience. An advanced degree is preferred.
You have 3-5 years of experience with a PhD degree, 5-7 years with a Master's degree, and 6-8 years with a Bachelor's degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experience in Regulatory Affairs.
You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
You have knowledge of regulations across different regions (preferably, 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 parts of global projects.
PreferredRegulatory affairs experience in the high-risk medical device industry.
LocationsYou are local to Tucson, Santa Clara, Branchburg, Indianapolis, Pleasanton, or any Roche Affiliate site. Remote work is considerable for this opportunity. West Coast work hours are highly preferred.*Relocation assistance is not available for this position.*The expected salary range for this position based on the primary location of Arizona is $99,400-$184,600. 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 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.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
Accommodations for Applicants .
#J-18808-Ljbffr
Apply locations Tucson, Santa Clara, Branchburg, Carlsbad, PleasantonTime type: Full timePosted on: Posted 2 Days AgoJob requisition id: 202411-129892Roche 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
A 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 companion diagnostics in International markets (i.e. all markets except US and EU). This role will specifically support our companion diagnostics 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 countries.The OpportunityYou oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of complex products/programs in International markets. You develop and manage parts of comprehensive global regulatory submissions and registration plans.
You interface with external stakeholders (such as pharma partners) and understand the structure, key roles, and responsibilities of external customers/stakeholders. You communicate timely and effectively the needs of external customers/stakeholders, building effective and enduring external relationships and applying effective stakeholder management practices.
You lead the organization to adapt to the evolving regulatory environment and requirements, interpreting and applying understanding of the regulators' thinking to projects and applying 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 the courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently, embracing good decision-making principles.
You model VAAC Leadership and agility, identifying opportunities to develop VACC competency. You act with integrity, courage, passion, and honor commitments while contributing to an inclusive environment that 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, bringing out the best in people and teams.
Who you areYou have a Bachelor’s/Master's degree in Life Science, Data Science, or related subject or equivalent experience. An advanced degree is preferred.
You have 3-5 years of experience with a PhD degree, 5-7 years with a Master's degree, and 6-8 years with a Bachelor's degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experience in Regulatory Affairs.
You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
You have knowledge of regulations across different regions (preferably, 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 parts of global projects.
PreferredRegulatory affairs experience in the high-risk medical device industry.
LocationsYou are local to Tucson, Santa Clara, Branchburg, Indianapolis, Pleasanton, or any Roche Affiliate site. Remote work is considerable for this opportunity. West Coast work hours are highly preferred.*Relocation assistance is not available for this position.*The expected salary range for this position based on the primary location of Arizona is $99,400-$184,600. 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 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.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
Accommodations for Applicants .
#J-18808-Ljbffr