Job Description
Key responsibilities : Knowledge of the registration process and local regulations Provides guidance for regulatory requirements of variations (CMC, Labelling, admin…) Provides guidance for regulatory requirements of new application requirements Interacts with RRL, Intercontinental CMC teams to ensure the filling of regulatory requirements per country for variations and renewal Responsible to review local labelling to compile with local requirements Qualifications A minimum of 2 years related experience in pharmaceutical/biotechnology, Regulatory Affairs in multinational industry. Professional Knowledge and skills Negotiation & communication skills Organization skills and high accuracy in documentation Analytical skills Ability to alert hierarchy in case of specific situation impacting his/her work environment Problem solving skills and sense of anticipation Presentation skills Interpersonal skills
