Covance

Coord Reg Sub

Job Location(s) CN-Beijing
Job Number
2021-62692
Job Category
Regulatory
Position Type
Full-Time
Telecommute
No

Job Overview

Responsible for providing support and assistance, under the direction of senior staff, in the
compilation and maintenance of clinical trials and marketing applications for submission to regulatory authorities.

Education/Qualifications

Bachelor’s or master's Degree in Life Sciences or equivalent

Experience

♦ Experience in HGRAC and/or CTA/IND application preferred.
♦ 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
correspondence).
♦ 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
submission documents.
♦ 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
duties.
♦ Perform other activities as required by management.

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