Global Regulatory Affairs Leader for Microbiome Therapeutics

2 weeks ago

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

Careerlink People Solutions is partnering with BiomeBank to present a unique opportunity for an experienced regulatory affairs professional.

BiomeBank, a clinical stage biotechnology company, aims to revolutionize disease treatment by restoring gut microbial ecology. With the recent announcement of the first regulatory approval for a donor-derived microbiome drug product worldwide, this role will play a pivotal part in shaping the company's growth and development.

The Role

This position reports directly to the Chief Operations Officer and involves developing and implementing global regulatory strategies for FDA, TGA, and EMA submissions. The ideal candidate will have expertise in managing project timelines and budgets while ensuring high-quality delivery that meets company goals.

Key Responsibilities:

  • Develop a clear regulatory strategy to lead all global submissions
  • Lead cross-functional teams for successful regulatory strategy drafting and submission
  • Manage project timelines and budgets to ensure high-quality delivery
  • Regularly review regulatory landscapes for live bacterial therapeutics in FDA, TGA, and EMA jurisdictions

The Ideal Candidate

We are seeking a highly skilled and experienced individual with a degree in biotechnology, biology, microbiology, or similar. The successful candidate will have advanced training in regulatory affairs, experience working with cell therapies, and a proven track record of providing strategic regulatory advice in US, AU, and EU jurisdictions.

Requirements:

  • Degree in biotechnology, biology, microbiology, or similar
  • Experience working with cell therapies
  • Advanced training in regulatory affairs
  • Proven track record of successful interactions with FDA/TGA/EMA and practicing sound judgment in relation to risk assessment
  • Leadership skills with ability to manage high volumes of work and competing priorities

Why Join Us?

This role offers the opportunity to take a pivotal part in the growth and development of the BiomeBank team, contributing to the expansion of the company in the microbiome research and novel therapies field. We value openness, quality, innovation, communication, and solution-oriented culture.

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