Job Description

Responsible for coordinating the preparation of documentation required for marketing authorisation application submissions by various departments and third parties.
Support the regulatory team in reviewing the quality and technical part of the dossier for marketing authorisation applications and responses to requests for further information associated with such applications.
Prepare responses to queries from the Health Authorities
Review variation packages for licensed products
Compiling Standard Operating Procedures, Working Instructions and Forms required in the Regulatory department.
Use Quality Management System (QMS) to propose any changes within the company related to a product or procedure.
Support the manager in developing software for internal use of preparing the submission dossier for marketing authorisation applications.
Support the manager in reviewing internal processes and provide guidance in implementing any changes.
Support the team with gap analysis between the registered dossier and plant practices through scheduled compliance checks.
Support the team with documentation throughout the product life cycle, from initial submission up to maintaining approval packages.
Train new members of the department
Keep up-to-date with Regulatory guidelines.
Supporting the manager with daily/activities which are required for the business

Regulatory Affairs and Pharmacovigilance Associate