Regulatory Affairs Project Manager

Join Roche

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.

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.

As a Regulatory Affairs Project Manager you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health authority marketing approvals, and utilize agile principles to drive regulatory activities for our Oncology In-vitro Diagnostics (IVD) team.

Your Opportunity

• You manage stakeholders by effectively communicating and partnering with them to understand and provide best solutions. You take initiative to address problems or opportunities and involve stakeholders for best solutions. You develop relationships that significantly influence the current and future direction for Roche and our products.
• You work on regulatory submissions, have a deep understanding of healthcare regulatory framework, and how to maintain compliance while accelerating innovation for customers and patients. You have a good understanding of complexities and challenges in a global regulatory environment.
• You hold strong leadership and live in the spirit of "We all lead" using VACC principles. You foster an exchange of ideas and support amongst colleagues. You have an agile mindset and actively develop this mindset and behavior while encouraging others to do so as well. You identify and act on opportunities for improvement within Quality & Regulatory, while embracing new technologies and other means to simplify and increase productivity.
• You have strong communication skills and can foster an exchange of ideas amongst key stakeholders to be able to shift perspectives. You encourage direct and open discussions about important issues.
• You value teamwork and collaboration and are able to pull people together around a common goal, seek to understand and build on different perspectives to enhance outcomes, and address and resolve conflict by creating an atmosphere of openness and trust.

Who You Are

• You have a Bachelor's or Master's degree in Life Science, Data Science or related subject. Equivalent experience will be considered. (Training as a technician or laboratory technician; or equivalent qualification for the tasks)
• You have 5+ years experience, (5-10 years preferred), in Regulatory, R&D, Quality, Operations and/or Clinical
• You have experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred.
• You can manage high complexity work and/or global projects, or equivalent experience.

Locations

This is an on-site role in Indianapolis, or Branchburg.

Relocation Assistance is not available for this opportunity.

The expected salary range for this position based on the primary location of Indiana is $84,600 to $157,200. 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.

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.