Senior Regulatory Affairs Associate (Safety/clinical LCM)

We are currently looking for a Senior Regulatory Affairs Associate who will have the following responsibilities: Strong understanding of regulatory labelling (and clinical) lifecycle maintenance activities across EU and ROW markets Change Control assessment experience or transferrable skills (application of relevant regulatory guidance to proposed change) Needs experience in: PSUR updates, management of CCDS updates and submission experience of simple and complex labelling variations to EU and RoW markets Capable of participating in discussion on regulatory strategies with a wide stakeholder network (Global Labelling, Supply, Brand Leads etc.) with support of an SME Strict adherence to timelines (both internal and HA deadlines) QualificationsIdeal candidate will possess: Very good understanding of performing the above regulatory tasks on global or EU level University degree within life sciences Fluent English and Romanian Very good Project Management skills Strong organizational and time management skills Strong communication and oral skills (F2F and virtual/TC) Good computer skills