Global Regulatory Affairs Lead
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?
In this position you will be managing the regulatory affairs in the pharmaceutical and healthcare field.
-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.)
-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
Apply to our vacancy for more or contact Nyasha Underwood at firstname.lastname@example.org.
Looking forward to chatting with you!