Regulatory Affairs Consultant (MAA)

We are currently looking for a Regulatory Affairs Consultant In Romania, who will have the following responsibilities: CMC gap analysis CMC authoring for INDs, MAAs, post approval variations/maintenance, annual reports (EU/US) Authoring and reviewing briefing books (CMC, clinical, non-clinical) HA Meeting preparation and support (incl. leading rehearsals) with the SMEs support Authoring and reviewing Paediatric Investigation Plans for EU (+UK) and Paediatric Study Plan (US) BLA/NDA authoring experience (CMC, clinical, non-clinical) Breakthrough therapy designation (US) Canada CTA authoring RIM and EDMS management Stakeholder management (legal, commercial supply etc.) Able to work under the direction of a sub-project lead and work alongside internal and external SMEs QualificationsRole requirements: University degree in life sciences Good understanding of performing the above regulatory tasks on a EU/global level Several years of CMC/clinical/non-clinical writing experience Very good Project Management skills Strong organizational and time management skills Strong communication skills (F2F and virtual/TC) Fluent English and Romanian