Job Description
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a contract opportunity for a Regulatory Affairs Associate in Raritan, NJ.
The Regulatory Affairs Associate will review and facilitate signing of documents including Power of Attorney, Letters of Authorization, etc. by internal and external partners, follow by tracking of notarization/legalization and shipment.
RESPONSIBILITIES
Track documents throughout the process and resolve issues related to delays or lost requests
Ensure documents are completed and arrive at affiliates before due dates
Significant amount of contact with international markets regional leads to clarify requirements, receipt of information, and critical timelines
Update status of specific projects upon request and debrief on market requests/ needs with project team
Provide weekly progress reports
Track project deliverables in SharePoint excel spreadsheet and monitor project status
Responsible for uploading submission documents to SharePoint and ERIS Electronic Regulatory Information System
Report directly to Senior Director AP LA, GRA and support global regulatory team
SKILLS
Basic understanding of drug development process and supply chain
Proficient in Microsoft Word and Excel
Good written communication skills
Attention to details and ability to track and organize a large number of submission documents
Professional demeanor on the phone with partners
EDUCATION/EXPERIENCE
Prior experience in international regulatory affairs preferred
B.S. degree in a biologic or chemical discipline
If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.
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 provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.
Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields.
Want more information? Visit kellyservices.com/science
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Job Requirements
Country: USA, State: New Jersey, City: Raritan, Company: Kelly Scientific Resources.
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