Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an experienced individual to work as a Vaccine Regulatory Scientist at the National Institutes of Health in Bethesda, MD.This is a long-term contract position which offers:+ Competitive compensation and comprehensive benefit package+ Optional health, vision, and dental plans+ Vacation leave as well as 10 paid federal holidays and 401K plan.+ Access to NIH’s unparalleled resources and niche scientific initiativesTASKS/SERVICES. The contractor shall:+ Responsible for chemistry, manufacturing and controls (CMC) information of all investigational new drug (IND) applications for vaccines, monoclonal antibodies, and related biological products.+ Assist regulatory program managers with CMC-relevant responses to comments from regulatory authorities.+ Oversee planning, preparation and review of Module 3 sections in Common Technical Document (CTD) format for submission to regulatory authorities+ Ensure documentation follows FDA guidelines and Code of Federal Regulations (CFR). Interacts collaboratively with VRC Office of Regulatory Sciences and Project Management groups.+ Serve as subject matter expert for Vaccine Production Program (VPP) process development staff for raw material sourcing and product testing strategies+ Interact with the VRC pilot plant manufacturing, regulatory and quality assurance staff. Reviews and provides comments, recommendations, and strategy on product specifications, stability protocols, comparability protocols and reports, investigator brochures and other related CMC documents during product development of biological products for early phase clinical trials.REQUIREMENTS. The contractor must have:+ Bachelor’s degree, M.S. preferred, in life science from an accredited college or university.+ Minimum of 8 years progressively responsible experience in Regulatory Affairs.+ Must have at least 5 years working with biologics/large molecules CMC preparation in the US.+ Must have direct experience assembling Regulatory applications in eCTD format.+ Must have demonstrated strong understanding of the U.S. Regulatory requirements.+ Must have Expertise in MS Office and SharePoint.**PLEASE APPLY ONLINE**When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients . We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.**Why Kelly** **®** **?**Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly® Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It’s just another way we make the job search work for you.**About Kelly** **®**Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.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. ()Tracking

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