¨ Under the direction of senior staff, assist with the formatting and compilation of regulatory
submissions through such tasks as entering information into Tables of Contents and creating
tabs and submission labels.
¨ Provide support assistance to senior staff in the upkeep of regulatory authority submission and
correspondence logs (add entries to Tables of Contents, file submission letters and other
¨ Generate routine submission cover letters to regulatory authorities and clients.
¨ Track, inventory and organize individual components of regulatory submissions.
¨ Perform document acceptability checks of submission components.
¨ Liaise with the Publishing group in the generation of submissions.
¨ Provide support assistance to senior staff in the oversight, final preparation and generation of
¨ Perform a quality check of final submission documents.
¨ Update status reports and tracking sheets of ongoing and pending regulatory projects with input
provided by senior staff.
¨ Organise shipping of documentation to clients, regulatory authorities and within Covance.
¨ Perform other job functions, such as word processing, as needed to accomplish the above listed
¨ Perform other activities as required by management.
Bachelor’s Degree in Life Sciences or equivalent (new Graduates are welcome)
¨Excellent verbal and written communication skills.
¨Computer literacy in basic functions (Word, Excel)
¨Good planning and organizational skills; detail oriented.
¨Flexibility, ability to switch back and forth between multiple projects/tasks.
¨Understanding/knowledge of drug regulations
¨Understanding of the drug development process
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