Regulatory Affairs Project Manager
Company: Disability Solutions
Location: Pleasanton
Posted on: October 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
PositionAs an International Regulatory Project Manager you will be
a member of CDx International CDx within the International
Regulatory Chapter.In this position you will focus on the support
and delivery of high quality regulatory submissions of companion
diagnostics to Health Authorities worldwide (except US/EU) for the
Roche portfolio.Your opportunity:
- Products for the respective area of responsibility shall obtain
Regulatory approvals in defined markets in close cooperation with
other functions.
- The documents/deliverables for submissions are coordinated and
compiled in a timely manner to support planned product registration
timelines.
- The obtained Regulatory approvals/ permits/licenses products
are maintained throughout the life cycle of the product by managing
successful health authority notifications and submission, in
accordance with quality management system change control
processes.
- Ensure efficiency and success of Regulatory activities and
strategies while collaborating closely with other functions,
stakeholders and external partners (authorities, companies, NBs
etc).
- Provide input to project and product regulatory strategy based
on international regulatory requirements and support international
regulatory submissions by provision of needed data and documents;
answering Health Authority questions on the submissions; keeping
our Affiliates informed about new products /projects/ process
changes etc.
- The regulatory requirements and strategic aspects are
understood, communicated and implemented, kept up to date and are
transparent within the organization.
- The activities are driven by a mindset of innovation, agility
and the principles of VACC leadership.Who your are:
- Bachelor's / Master degree in Life Science, Data Science or
related subject or equivalent experience (Completed training as a
technician or laboratory technician; or equivalent qualification
for the tasks)
- You have 5+ years experience, (5-10 years preferred) experience
in Regulatory, Clinical and/or Quality
- Experience in diagnostics or pharmaceutical regulatory affairs
is required
- Advanced degree and experience in CDx is considered an
advantage.
- Can manage high complexity work and/or global projects, or
equivalent experience.
- Proven ability to work autonomouslyAre you ready to apply? We
want someone who thinks beyond the job offered - someone who knows
that this position can be a unique opportunity to shape the future
of Roche.LocationsYou are local to Pleasanton, Santa Clara,
Branchburg, Indianapolis, or Tucson. Relocation assistance is not
available for this opportunity.The expected salary range for this
position based on the primary location of California is $96,000 and
$178,200. 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.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.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 .
Keywords: Disability Solutions, Watsonville , Regulatory Affairs Project Manager, Executive , Pleasanton, California
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