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28 days old

Regulatory Affairs Specialist

Kelly Services
Palo Alto, CA 94301
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. Ideal candidate must have CMC experience.



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 to date

+ 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 GDP.

+ Participate with Regulatory software installation and maintenance.

+ 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



Requirements:




+ 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



Apply today for immediate consideration!




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional 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 do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-12-25 Expires: 2021-01-25

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Regulatory Affairs Specialist

Kelly Services
Palo Alto, CA 94301

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