Senior Regulatory Officer

1 week ago


Melbourne, Victoria, Australia beBeeRegulatoryAffairs Full time $90,000 - $130,000

Regulatory Affairs Role Overview

This is an exciting opportunity to join a Global Regulatory Affairs team as a key member. You will play a crucial role in supporting the preparation and submission of marketing applications and variations for new or life cycle products.

Main Responsibilities

  • Prepare and submit marketing applications and variations for new or life cycle products.
  • Assist in the preparation of regulatory components of life cycle documents such as PSURs and annual reports.
  • Prepare dossier preparation check/tracking lists and request missing documents from operational departments.
  • Review guidelines and coordinate comments.
  • Work with product managers/specialists to prepare Module 1 documentation.
  • Enter and maintain data in regulatory systems and provide outputs for audit requests.
  • Work with relevant product managers/scientists to prepare standard operating procedures/work instructions or check/tracking lists.
  • Monitor metrics/statistics, reports, and training requirements.

Key Requirements

  • Entry-level qualification in a science-related field or proven regulatory experience.
  • Function-related training in Regulatory Affairs.
  • Flexibility to work in a global regulatory cross-cultural environment.
  • Team player with effective relationship-building skills.
  • Awareness of regulatory affairs.

Why This Role Matters

This role offers a chance to make a significant impact in the development and submission of marketing applications and variations. If you are passionate about regulatory affairs and have excellent communication skills, this could be the perfect opportunity for you.



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