Regulatory Affairs and Pharmacovigilance Associate
|Job Title:||Regulatory Affairs and Pharmacovigilance Associate|
|Contact Name:||Alastair McCartney|
|Job Published:||August 01, 2017 09:31|
- 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
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