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Regulatory Affairs and Pharmacovigilance Associate

Regulatory Affairs and Pharmacovigilance Associate

Job Title: Regulatory Affairs and Pharmacovigilance Associate
Contract Type: Contract
Location: London, England
Industry:
Salary: Negotiable
Reference: RAPV101_1501576313
Contact Name: Alastair McCartney
Contact Email: a.mccartney@sciproglobal.com
Job Published: August 01, 2017 09:31

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