Regulatory Affairs Project Manager

Company: Disability Solutions
Location: Tucson
Posted on: May 4, 2024

Job Description:

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 PositionA 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 Companion Diagnostics Group (CDx).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.
  • You can manage high complexity work and/or global projects, or equivalent experience.LocationsThe primary job location for this role is Tucson Arizona, however we will consider other locations in the United States. Roche Diagnostics sites preferred (Pleasanton, Indianapolis, Branchburg).Relocation Benefits are not available for this opportunity.The expected salary range for this position based on the primary location of Arizona is $81,300 and $151,100. 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.Who we areAt 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.Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.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.

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