As Regulatory Affairs Specialist or Analyst you will assist in the support of the daily operational activities within Regulatory Affairs for the collection, tracking, filing, and storage of clinical trial documents. Moreover, you will support the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals and device products in the domestic and international markets as assigned.
- Support of daily operational activities
- Collect, track, file, and store clinical trial documents
- Assist with preparation of regulatory submissions
- Maintenance systems designed to ensure compliance with electronic submission requirements and document management systems
- Education: Bachelor’s Degree. In lieu of degree, additional years of relevant experience may be considered. Furthermore, candidates with Library Science Degrees with applicable background and experience will be considered as well.
- 0 – 2 years related experience
- Experience with document management a plus
- Understanding of document management processes in a regulated pharmaceutical/device environment
If you are interested in this opportunity, please forward your resume to firstname.lastname@example.org. Please specify the position you’re interested in, in the subject line.
InGeneron would like to thank all applicants, however only those who qualify for an interview will be contacted.