Regulatory Expertise Lead

4 days ago


Melbourne, Victoria, Australia beBeeRegulatory Full time $120,000 - $140,000
Senior Regulatory Affairs Associate

This role focuses on established products and offers a unique mix of submission responsibility, strategic contribution, and cross-functional collaboration.

The successful candidate will be part of a collaborative and diverse team environment where initiative is recognised and regulatory professionals are seen as strategic business partners.

Key Responsibilities:
  • Preparation and management of regulatory submissions
  • Leadership in preparing documentation for health authority meetings
  • Collaboration with global regulatory leads
  • Submission of regulatory documentation
  • Response to health authority queries
  • Filing of CAT 1 and CAT 3 applications
Requirements:
  1. A degree in Biological or Medical Science, Pharmacy, or a related field
  2. Postgraduate studies in Regulatory Affairs as a strong advantage
  3. Minimum 3+ years' experience in a regulatory affairs role with a focus on pharmaceuticals
  4. Strong knowledge of TGA requirements and regulatory frameworks
  5. Understanding of GMP, GCP, and GLP
What We Offer:

This role offers a unique opportunity to work in a dynamic and fast-paced environment with a talented team of professionals.

As a Senior Regulatory Affairs Associate, you will have the opportunity to develop your skills and expertise in a supportive and collaborative environment.



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