Regulatory Affairs Director

3 weeks ago

Sydney, New South Wales, Australia Careerlink People Solutions Full time

BiomeBank is a clinical stage biotechnology company with a mission to treat and prevent disease by restoring gut microbial ecology.

The company has proudly announced the first regulatory approval for a donor-derived microbiome drug product worldwide.

We are seeking a proactive individual with an analytical mindset to join our team as Head of Global Regulatory Affairs.

This role is responsible for developing and implementing global (FDA, TGA, EMA) regulatory strategy, filings, product development requirements leading to successful product registration and life-cycle management of unique and technologically complex microbial therapeutics serving patients with unmet medical needs.

Key responsibilities include:

  • Developing a clear regulatory strategy to lead all regulatory submissions worldwide
  • Leading a cross-functional team to ensure successful regulatory strategy, drafting, and submission
  • Management of project timelines and budgets, ensuring high-quality delivery to meet company goals
  • Regular reviews of regulatory landscape regarding live bacterial therapeutics (cultured and donor-derived) for FDA, TGA, EMA as new guidance develops and is published

Requirements include:

  • Degree in biotechnology, biology, microbiology or similar
  • Experience working with cell therapies
  • Advanced training in regulatory affairs
  • Experience providing strategic regulatory advice US, AU, EU jurisdictions through all stages of development including pre-approval and marketed products
  • Experience leading major FDA submissions and FDA meetings
  • Proven track record of successful interactions with FDA/TGA/EMA and practicing sound judgment in relation to risk assessment
  • Highly conversant and knowledgeable of new and emerging regulations and guidance, including understanding of GMPs and GCPs
  • Demonstrated leadership skills with proven ability to manage high volumes of work and competing priorities

This role will give you the opportunity to take a pivotal role in the growth and development of the BiomeBank team in their expansion, and be a crucial leader within a dynamic and multi-cultural team.

We are a close-knit, passionate and innovative team at the forefront of microbiome research and working with novel therapies.

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