Associate, Regulatory Operations
The Associate of Regulatory Operations will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production,
document publishing, and document management. In addition to assigned projects, responsibilities include evaluation of current processes and systems with regard to industry best practices,
available resources, and evolving U.S. and international regulations and guidelines. Then, based on such evaluations, propose changes targeting greater efficiency and continued compliance.
Maintains the Regulatory Archives, electronic files, and communications databases
Must have 5+ years relevant experience
Expertise in Microsoft Office and Adobe Acrobat software
Thorough knowledge of CTD/eCTD format and FDA submission requirements
Proficient with Microsoft Office products and Adobe Acrobat
Advanced skills with submission publishing software
Candidates must live local and be a US Citizen or Green Card Holder
Email resume to: firstname.lastname@example.org
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
Commonwealth Sciences, Inc.