Regulatory Affairs Manager

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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 our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys immunoassay product portfolio. Our dynamic team manages regulatory projects as well as overarching regulatory topics. Join an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.

The Opportunity: Your Main Purpose and Tasks

In this impactful role, you will:

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

• Manage neurology, cardiology and core reagents product registrations in the United States, Europe and China 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 bodies 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.

What You Bring to the Team: Your Essential Toolbox

To excel in this role, you should possess:

• 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 with significant experiences in Regulatory Affairs or equivalent.

• Technical understanding of medical devices or IVDs

• In-depth knowledge of immunoassays is highly desirable

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

• The ability to work independently, reliably, and with exceptional flexibility, allowing you to effectively shift priorities and balance multiple commitments.

• Proven experience in managing overlapping projects, showcasing your strong ability to juggle multiple tasks, multitask efficiently, and maintain excellent self-organization.

• A collaborative spirit, recognizing and valuing the contributions of your teammates and peers, and leveraging strong relationships to achieve key results.

Locations

You are local to Indianapolis, Indiana. We will consider remote work arrangements under extraordinary circumstances.

*Relocation assistance is not available for this position.*

The expected salary range for this position based on the primary location of Indiana is $104,000-$193,000. 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

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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.