Regulatory Affairs Specialist

3 weeks ago


Sydney, New South Wales, Australia Novartis Full time

Regulatory Affairs Role Overview

We are seeking a highly experienced Regulatory Affairs Specialist to join our team at Novartis. As a key member of our team, you will play a critical role in determining the optimal regulatory pathway to accelerate the approval process.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  • Collaborate with cross-functional teams to ensure alignment on regulatory submissions and strategies.
  • Provide regulatory expertise to support business development initiatives and ensure a seamless approval process.
  • Stay up-to-date with regulatory changes and updates to ensure our submissions meet the latest requirements.

Essential Requirements:

  • Relevant degree in a scientific field, such as Pharmacy, Medicine, or a related field.
  • Proven track record of innovation, technical competence, and successful business outcomes in Regulatory Affairs.
  • Broad experience in regulatory affairs, dealing with and solving complex business and/or regulatory issues.

Why Novartis?

At Novartis, we reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. Join us and be part of a team that drives innovation and excellence in Regulatory Affairs.



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