Regulatory Affairs Manager

Company: F. Hoffmann-La Roche AG
Location: Pleasanton
Posted on: November 8, 2024

Job Description:

Regulatory Affairs Manager Locations: Indianapolis, Santa Clara, Branchburg, Pleasanton, Tucson Time Type: Full time Posted on: Posted Today Job Requisition ID: 202411-128112 Roche 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. This role will specifically support our Diabetes Care portfolio in our Blood Glucose Monitoring customer area. The Opportunity

• You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs.
• You interface with external management and build effective and enduring external relationships.
• You lead the organization to adapt to the evolving regulatory environment and requirements.
• You effectively partner with stakeholders to provide best solutions.
• You have the courage to make decisions even outside of your comfort zone.
• You model VACC Leadership and agility, contributing to an inclusive environment.
• You are able to pull people together around a common goal and resolve conflicts effectively. 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.
  • You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
  • You have successful IVD or medical device submission experience with the FDA and knowledge of international regulations.
  • You have demonstrated the ability to manage more complex work and/or parts of global projects. Locations You must be local to a US Diagnostics site in Indianapolis, Pleasanton, Santa Clara, Tucson, or Branchburg. Relocation assistance is not available for this position. The expected salary range for this position based on the primary location of Indianapolis is $99,900-$185,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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. Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any characteristic protected by law.
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