F. Hoffmann-La Roche AG
Companion Diagnostics Regulatory Affairs Manager
F. Hoffmann-La Roche AG, Carlsbad, California, United States, 92002
Companion Diagnostics Regulatory Affairs ManagerLocations: Tucson, Santa Clara, Branchburg, Carlsbad, PleasantonTime Type: Full TimePosted On: 2 days agoJob Requisition ID: 202411-129892Roche fosters diversity, equity, and inclusion, representing the communities we serve. 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
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.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 interface with external stakeholders (such as pharma partners) to understand their needs and communicate effectively.
You lead the organization to adapt to the evolving regulatory environment and requirements.
You effectively partner with stakeholders to understand and provide best solutions.
You have the courage to make decisions and proactively initiate activities independently.
You model VAAC Leadership and agility, contributing to an inclusive environment.
You can pull people together around a common goal and resolve conflict by creating an atmosphere of openness and trust.
Who You Are
You have a Bachelor’s/Master’s degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
You have 3-5 years of experience with a PhD, 5-7 years with a Master’s, and 6-8 years with a Bachelor’s 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 and the ability to interpret and implement quality standards.
You have demonstrated the ability to manage complex work and/or parts of global projects.
Preferred:Regulatory affairs experience in the high-risk medical device industry.
Locations
You 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.Who We Are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. 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.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s characteristics 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 .
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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.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 interface with external stakeholders (such as pharma partners) to understand their needs and communicate effectively.
You lead the organization to adapt to the evolving regulatory environment and requirements.
You effectively partner with stakeholders to understand and provide best solutions.
You have the courage to make decisions and proactively initiate activities independently.
You model VAAC Leadership and agility, contributing to an inclusive environment.
You can pull people together around a common goal and resolve conflict by creating an atmosphere of openness and trust.
Who You Are
You have a Bachelor’s/Master’s degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
You have 3-5 years of experience with a PhD, 5-7 years with a Master’s, and 6-8 years with a Bachelor’s 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 and the ability to interpret and implement quality standards.
You have demonstrated the ability to manage complex work and/or parts of global projects.
Preferred:Regulatory affairs experience in the high-risk medical device industry.
Locations
You 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.Who We Are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. 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.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s characteristics 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 .
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