Group 10

In the context of team expansion, we are looking for a new regulatory assistant to join our dynamic international teams for the following missions directly at the client’s place:

  • RA archive management in the headquarter in Valby in line with compliance (GXP, internal SOPs and company Policies)
  • Receiving incoming documents, indexing those and electronic registering/archiving, physical filing of paper docs
  • On request (in case of inspections or audits), locate archived documents and provide those to the requesting department
  • Once those are returned, index and archive them again
  • Clean documents in line with the documentation retention limits
  • Special projects in case the company sells products, all relevant RA docs need to be sent to buyer and removed from archive
  • And vice versa, if the company buys product, archive the incoming docs
  • Order boxes, binders, stickers, labels, pallets etc. needed for delivering to archiving tasks
  • Managing incoming post
  • Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
  • Assist in the management of ProductLife Quality Management System
  • To participate in training as required for ProductLife staff
  • To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.

Group 13

  • Currently studying for a bachelor or master’s degree related with Library & Information science
  • Excellent organizational and interpersonal skills
  • Ability to work well within a team
  • Process orientated with good attention to detail
  • Effective oral and written communication skills
  • Good computer skills and the ability to learn appropriate software
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  • Good English language and grammar skills (written fluency a must, verbal fluency preferred), at least one Nordic language mastered is a plus

Student Regulatory Affairs Assistant 437