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.
Keywords: Disability Solutions, Catalina Foothills , Regulatory Affairs Project Manager, Executive , Tucson, Arizona
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