A state of the art facility is looking for a Regulatory Affairs
Specialist to join the team in developing cutting edge
biologics. This is a permanent opportunity.
Title: Regulatory Affairs Specialist
Develop and manage IND submissions and create policies and
procedures to ensure compliance with FDA and cGMP.
What will you do?
Assist with managing and coordinating the author, review,
and finalization of regulatory documents in accordance with
submission timelines, keeping stakeholders and external partners up
Support preparation of clinical, pre-clinical, and CMC
information for submissions of Investigational New Drugs (INDs)
Executes and maintains processes for managing regulatory
submissions, correspondences, and commitments in accordance with
Participate with Regulatory software installation and
Support the development of responses to Health Authority
requests and ensure alignment with regulatory CMC strategy.
Assist in drafting background packages for meetings.
Support facility licensing and registration, GMP validation
activities of cell processing facility and other cGMP/GLP
activities (change controls, QSR implementation, SOP and RMS
reviews) via direct interactions with QA
Training of regulatory staff
Other duties may also be assigned
Bachelor's Degree required; PhD preferred
At least 5 years of cell or gene therapy experience
Knowledge of CMC, ICH, and US regulatory documents
Experience with investigational stage biologics
This is a great opportunity for someone who is looking to make
the move from Research into Regulatory Affairs. Apply today
for immediate consideration!
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just like you. Every day, we match science professionals with dream
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have a professional background/education in science, so we know a
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About Kelly ®
At Kelly, we’re always thinking about what’s next and advising
job seekers on new ways of working to reach their full potential.
In fact, we’re a leading advocate for temporary/non-traditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
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workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a
diverse workforce and providing accommodations for people with
disabilities in all parts of the hiring process as required under
its Employment Accommodation Policy. Kelly will work with
applicants to meet accommodation needs that are made known to Kelly