Regulatory Affairs Professional - MAA

Parexel International Corporation

Additional Locations: Zagreb,,Croatia

Parexel Croatia is currently looking for an experienced Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients. This will be a client dedicated role focusing on Marketing Authorization Applications.

In this role you will provide leadership in all regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible with delivering submission specific milestones, while also providing guidance to the client on submissions strategies. You will support MAA submissions in Croatia and Slovenia: Lifecycle maintenance (Variations, renewals, etc), Marketing Authorization Transfer; and subsequent Regulatory Affairs work. You will also bring to the role some insight on local pharmacovigilance intelligence for Slovenia and Croatia.

Local Regulatory Affairs support may include (but is not limited to):

any local submission document preparation and translations
product info and translations
mock-up review
annual payments
proof of payment
local intelligence
support dialogue with local HA as appliable

Ideal candidate will possess:

University degree in life science discipline
Significant CRO/Pharma experience within Regulatory
Solid analysis and synthesis capability; Solution-oriented and problem-solving skills
Fluency in English is a must along with the local language
Solid MAA knowledge and experience
Project Management experience
Fluent English and local language