Roche Holdings Inc.
Regulatory Affairs Project Manager
Roche Holdings Inc., Pleasanton, California, United States, 94566
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 Position
As an International Regulatory Project Manager, you will be a member of CDx International CDx within the International Regulatory Chapter.In this position, you will focus on the support and delivery of high-quality regulatory submissions of companion diagnostics to Health Authorities worldwide (except US/EU) for the Roche portfolio.Your opportunity:Products for the respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions.The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines.The obtained Regulatory approvals/permits/licenses products are maintained throughout the life cycle of the product by managing successful health authority notifications and submission, in accordance with quality management system change control processes.Ensure efficiency and success of Regulatory activities and strategies while collaborating closely with other functions, stakeholders and external partners (authorities, companies, NBs etc).Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provision of needed data and documents; answering Health Authority questions on the submissions; keeping our Affiliates informed about new products/projects/process changes etc.The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization.The activities are driven by a mindset of innovation, agility and the principles of VACC leadership.Who you are:
Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience (Completed training as a technician or laboratory technician; or equivalent qualification for the tasks).You have 5+ years experience, (5-10 years preferred) experience in Regulatory, Clinical and/or Quality.Experience in diagnostics or pharmaceutical regulatory affairs is required.Advanced degree and experience in CDx is considered an advantage.Can manage high complexity work and/or global projects, or equivalent experience.Proven ability to work autonomously.Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a unique opportunity to shape the future of Roche.Locations
You are local to Pleasanton, Santa Clara, Branchburg, Indianapolis, or Tucson. Relocation assistance is not available for this opportunity.The expected salary range for this position based on the primary location of California is $96,000 and $178,200. 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.Benefits
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.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 .
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As an International Regulatory Project Manager, you will be a member of CDx International CDx within the International Regulatory Chapter.In this position, you will focus on the support and delivery of high-quality regulatory submissions of companion diagnostics to Health Authorities worldwide (except US/EU) for the Roche portfolio.Your opportunity:Products for the respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions.The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines.The obtained Regulatory approvals/permits/licenses products are maintained throughout the life cycle of the product by managing successful health authority notifications and submission, in accordance with quality management system change control processes.Ensure efficiency and success of Regulatory activities and strategies while collaborating closely with other functions, stakeholders and external partners (authorities, companies, NBs etc).Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provision of needed data and documents; answering Health Authority questions on the submissions; keeping our Affiliates informed about new products/projects/process changes etc.The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization.The activities are driven by a mindset of innovation, agility and the principles of VACC leadership.Who you are:
Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience (Completed training as a technician or laboratory technician; or equivalent qualification for the tasks).You have 5+ years experience, (5-10 years preferred) experience in Regulatory, Clinical and/or Quality.Experience in diagnostics or pharmaceutical regulatory affairs is required.Advanced degree and experience in CDx is considered an advantage.Can manage high complexity work and/or global projects, or equivalent experience.Proven ability to work autonomously.Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a unique opportunity to shape the future of Roche.Locations
You are local to Pleasanton, Santa Clara, Branchburg, Indianapolis, or Tucson. Relocation assistance is not available for this opportunity.The expected salary range for this position based on the primary location of California is $96,000 and $178,200. 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.Benefits
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.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 .
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