Regulatory Affairs Associate- Bohemia, New York 11716
As part of the Biotech Regulatory Affairs group, the Regulatory Affairs Associate will be responsible for researching regulatory information pertinent to the products manufactured & distributed or services rendered in North America. You will be responsible for collating and distributing the information to the proper personnel within the company.
• Compile reports on industry regulatory issues, warnings and potential changes.
• Proactively monitor US Regulatory Sources (FDA, USDA, Health Canada etc.)
• Prepare monthly report on all new regulatory information obtained.
• Support and expand the use of LEAN tools to drive RA process improvements.
• Maintain regulatory knowledge by attending education workshops, reviewing publications, establishing networks and industry practices.
• Assist with overflow in other regulatory areas and other projects.
Bachelor's degree. Preferably in Biology, Biochemistry, Pharmaceutical Science, Chemistry, Engineering or a long-term professional experience in related fields.
• 3 years' experience reaching collecting data in a regulatory environment.
• Excellent attention to detail and savvy with MS office suite
• Experience in SAP preferred but not required.
• Preferred experience in biotech, pharma or pharmaceutical industry.
• Experience in regulated industries and knowledge of Quality Systems practices and related regulations is a plus.
• Knowledge of project administration
Kelly® Science 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 interests—it's 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, 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/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.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website