Regulatory Manager

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

 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 Global Regulatory Affairs, we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Focus of our work in the Subchapter Cardiology, Endocrinology and Fertility is the global approval of in-vitro-diagnostics of the Core Lab and Point of Care product portfolio. Our team is tasked with regulatory projects as well as overarching regulatory topics. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties. 

The Opportunity

• Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams in order to create an impactful and fruitful work environment. 

• You will manage neurology, cardiology and core reagents product registrations in Europe, China and the United States and support worldwide registrations.

• Give regulatory guidance on both strategic and tactical topics to stakeholders and cross-functional project teams of the appropriate customer areas.

• Prepare and submit premarket submissions to FDA or Notified body serving as the primary interface.  Interact with regulatory agency personnel in order to expedite approval or clearance of pending registration and answers any questions

• Be accountable for supporting product care activities and updating the technical documentation of the product portfolio.

• In order to achieve efficient approvals worldwide, you work in close collaboration with colleagues in Germany, Switzerland and the US within and across chapters as well as with  global Regulatory Affairs teams, especially in China and Japan.

Who you are

• Advanced degree in Biology, Pharmacy, Chemistry, Engineering  or related field

• 5 years of proven experience in Regulatory / R&D / Medical / Scientific Affairs / Quality in the diagnostics industry or a related field

• Technical understanding of medical devices or IVDs

• In-depth knowledge of immunoassays or Roche Point-of-Care solutions is highly desirable

• Knowledge in international laws and regulations for development,  manufacturing and registration of IVDs especially in EU, US and China

• Experience in working on overlapping projects - i.e. good at juggling multiple projects, multitasking and organizing yourself

• Project management expertise in an agile environment

As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of Indianapolis, Indiana is $100,000 - 185,600.  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.

Benefits

Salary Range: SE7 / AT1

Your Application

Please upload your resume in English. Additional documents will be requested if required.

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.

As a global lead