Regulatory Affairs Project Manager

Roche • Indianapolis, IN

3d • $84,600 - $157,200 • Onsite

About The Position

At Roche, we foster a culture where you can show up as yourself, embraced for your unique qualities. 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. 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. You will manage stakeholders by effectively communicating and partnering with them to understand and provide the best solutions. You will take initiative to address problems or opportunities and involve stakeholders for the best solutions. You will develop relationships that significantly influence the current and future direction for Roche and our products. You will work on regulatory submissions, have a deep understanding of the healthcare regulatory framework, and how to maintain compliance while accelerating innovation for customers and patients. You will have a good understanding of complexities and challenges in a global regulatory environment. You will hold strong leadership and live in the spirit of "We all lead" using VACC principles. You will foster an exchange of ideas and support amongst colleagues. You will have an agile mindset and actively develop this mindset and behavior while encouraging others to do so as well. You will 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.

Requirements

• 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
• 5+ years experience (5-10 years preferred) in Regulatory, R&D, Quality, Operations and/or Clinical
• Experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred.
• Ability to manage high complexity work and/or global projects, or equivalent experience.
• Strong leadership and live in the spirit of "We all lead" using VACC principles.
• Agile mindset and actively develop this mindset and behavior while encouraging others to do so as well.
• Strong communication skills and can foster an exchange of ideas amongst key stakeholders to be able to shift perspectives.
• Value teamwork and collaboration.

Responsibilities

• Manage stakeholders by effectively communicating and partnering with them to understand and provide best solutions.
• Take initiative to address problems or opportunities and involve stakeholders for best solutions.
• Develop relationships that significantly influence the current and future direction for Roche and our products.
• Work on regulatory submissions, have a deep understanding of healthcare regulatory framework, and how to maintain compliance while accelerating innovation for customers and patients.
• Foster an exchange of ideas and support amongst colleagues.
• Identify and act on opportunities for improvement within Quality & Regulatory, while embracing new technologies and other means to simplify and increase productivity.
• Encourage direct and open discussions about important issues.
• 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.

Benefits

• Relocation Assistance is not available for this opportunity.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior