Regulatory Affairs Project Manager

Roche•Indianapolis, IN

1d•$84,600 - $157,200•Onsite

About The Position

At Roche, we are driven by a mission to create a healthier future and ensure everyone has access to the healthcare they need. As a Regulatory Affairs Project Manager, you will play a crucial role in project and product realization, working with internal and external teams. Your responsibilities will include preparing submission packets for health authority marketing approvals and applying agile principles to regulatory activities within our Oncology In-vitro Diagnostics (IVD) team. You will manage stakeholders through effective communication and collaboration, proactively address challenges and opportunities, and build influential relationships that shape the future of Roche and its products. A deep understanding of healthcare regulatory frameworks, compliance, and global regulatory complexities is essential. You will embody leadership through the VACC principles, fostering idea exchange and mutual support among colleagues. An agile mindset is key, and you will be expected to develop and encourage this mindset in others, identifying opportunities for improvement within Quality & Regulatory, and embracing new technologies to enhance productivity. Strong communication skills are vital for fostering direct and open discussions, shifting perspectives, and resolving conflicts through an atmosphere of trust and openness. Teamwork and collaboration are highly valued, with an emphasis on pulling people together around common goals and building on diverse perspectives.

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 skills.
Agile mindset.
Strong communication skills.

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 its products.
Work on regulatory submissions.
Maintain compliance while accelerating innovation for customers and patients.
Foster an exchange of ideas and support amongst colleagues.
Actively develop an agile mindset and behavior while encouraging others to do so as well.
Identify and act on opportunities for improvement within Quality & Regulatory, while embracing new technologies and other means to simplify and increase productivity.
Foster an exchange of ideas amongst key stakeholders to be able to shift perspectives.
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.