Global Regulatory Affairs Lead Radom, Mazowieckie

Global Regulatory Affairs Lead

Amsterdam, zagranica, Polska

Opis stanowiska pracy

The Company
Our client is a multinational pharmaceutical and healthcare company who provide potentially life-changing treatments and the protection of life-saving vaccines to millions of people worldwide. Will you be their next team member?
 
Role Description
In this position you will be managing the regulatory affairs in the pharmaceutical and healthcare field.
 
Responsibilities
-Management and conduct of the Global regulatory activities for assigned projects in line with regulatory requirements.
-Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions such as Clinical Trial Applications (CTA)/Investigational New Drug (IND), amendments, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
-Coordinate required documentation in coordination with Chemistry, Manufacturing and Controls (CMC) Team or Functional group
-Interfacing with global Regulatory partners and internal cross functional teams and will require to work in a matrix environment (transversal collaboration, project teams etc. )
 
Requirements
-Master of Science in Life Sciences/ Management Sciences (ie. Pharmacy, Chemistry or Biology).  
+3 years of regulatory experience with basic regulatory knowledge of EU and US
-Ideally experience in Big/Major pharma
-IND/ Clinical Trial Applications (CTA) experience
-NDA/ BLA/MAA experience if possible
-English
 
Other information
Apply to our vacancy for more or contact Nyasha Underwood at n. underwood@sire-search.com.
Looking forward to chatting with you!