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Regulatory Affairs Life Cycle Management

3 settimane fa

Milano, Italia IQVIA A tempo pieno

[15:45] Cardano, Sara

Our client, **Chiesi Farmaceutici **- one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a **Regulatory Affairs Life-Cycle Management Unit Junior Specialist **who can join an exciting working environment in a dynamic and international atmosphere.

The Regulatory Affairs Life-Cycle Management Unit Specialist is in charge of managing regulatory aspects of projects intended for lifecycle management of approved Marketing Authorisations. This includes preparing and maintaining dossier documentation for licence variations in all the Region “China and International”.

**CMC and labelling Regulatory activities**:
**TASKS**:

- Quality and clinical variations to existing Marketing Authorisations (MAs) in all the “China and International” Region (in cooperation with RA colleagues concerned, where necessary)
- Preparation/Completion of the package required for submission of the variations to existing MAs in all the “China and International” (in cooperation with the Life-Cycle Management Team Staff, the UCRD Staff, QA Manager and/or Specialists, CMT (Corporate Manufacturing Technology) Head and/or Specialists, QC Manager and/or Specialists, GRA CMC Group, GCD (Global Clinical Development) Staff and the “China and International” RA colleagues concerned, if necessary)
- Other quality and clinical issues in all the “China and International” Region (in cooperation with GRA CMC group and the RA colleagues concerned)

To participate, whenever necessary, in the Life-Cycle Management Team, UCRD and in the R&D Core Team meetings, when the latter are addressed to life-cycle activities.

To support the RAMs on Renewals of existing MAs in all the “China and International”, whenever such renewals entail concomitant changes to the quality and clinical part of the existing MA dossiers.

**REQUIREMENTS**:

- University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology
- At least two years of experience within Regulatory Affairs
- English knowledge

**TYPE OF CONTRACT**:
Permanent contract

Chemical contract