Regulatory Affairs Officer

RAOFFICER_1717051914
  • Republic of Ireland
  • Contract

Regulatory Affairs Officer

Initial 6 Month Contract, temp - perm, performance dependent.

Flexible hourly rate (experience dependent).

16 hours/week contract.

Fully remote role must be EU based.

Responsibilities include:

  • Responsible for the preparation of SmPC, labelling and PILs texts according to the clients Quality Review of Documents (QRD) format.
  • Responsible for text verification in all European languages of the client's product information documents.
  • Responsible for proof reading of artwork of packaging materials.
  • User of IT standards, like eCTD, XEVMPD.
  • User of IT systems like AMS, Trackwise, eDMS, eLMS, OneHR.
  • Able to write standard operating procedures.

Experience/Skills required:

  • Bachelor or Masters degree.
  • 3+ years of regulatory labelling experience required.
  • Good knowledge of the EU Regulatory Framework (directives, regulations, guidelines).

If you are interested, please contact me on my details below.

Hamish Corson
Senior Business Manager, UK/EU GxP Contract Division
+44 20 3326 4116 (UK)/+353 1 485 4994 (IE)/+31 20 808 1524 (NL)
HCorson@i-pharmconsulting.com

Hamish Corson Senior Business Manager

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