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Senior Regulatory Affairs Executive

Quanta - Australia,

Health, Medical & Pharmaceutical
Source: uWorkin


Are you looking for a step up into a senior position with a well known Pharmaceutical company with offices across the Globe?

I am currently recruiting for a Senior Regulatory Affairs Executive to work in a permanent position. This is an excellent opportunity to develop your skills and work for a company with great career prospects

Role Overview

To assist in the process of development of new products, attaining and maintaining Product Marketing Authorisations.

Duties and Responsibilities Will Include:

  • Compilation of registration dossiers for submission to EU and non-EU regulatory authorities
  • Preparation and submission of variation applications to existing MAs
  • Pharmacovigilance – preparation of PSURs, logging, investigating and reporting of adverse reactions
  • Review of process validation protocols, analytical method validation and stability reports for inclusion in Part II of the dossier
  • Review of Drug Master Files
  • Writing of reports for European MAs
  • Assist in the project management of both internal and external R&D projects
  • Artwork review and approval

Skills and Qualifications Needed

  • Scientific qualification and background preferably B.Sc. or equivalent
  • Minimum 3 years in a Regulatory/R&D environment preferably with experience of generic applications
  • Pharmaceutical / Bio-pharmaceutical / Animal Health experience
  • Experience in busy problem solving environment with the ability to work on multiple projects simultaneously

If this sounds like the job for you, please apply now and a representative will be in touch shortly!

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