Global Regulatory Affairs Manager (homebased)

No visa or accommodation sponsorship

You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s)

As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies.

JOB OVERVIEW

Essential Functions

•Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries

•Submit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and EMA and follow up on the local regulatory approval process for designated countries

•Preparation of local Product Labelling (e....