Job Description
JOB SUMMARY
Under the supervision of line management or guidance from an experienced Senior Regulatory Manager, conduct agreed strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.
JOB RESPONSIBILITIES
Deliver Regulatory Strategy and Advise Cross-Functional Teams
Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
Manage New Registration/Marketing Authorization Applications
Manage Marketing Authorization (MA) Variation Applications
Manage MA Renewal Applications
Management of NRA queries
Develop knowledge of NRA’s expectations, ways of working etc. to inform assigned product regulatory strateg...