Head of Global Regulatory Affairs
Careerlink People Solutions are partnering with BiomeBank to present a rare opportunity for a proactive individual with an analytical mindset to join the team as Head of Global Regulatory Affairs.
BiomeBank is a clinical stage biotechnology company with a mission to treat and prevent disease by restoring gut microbial ecology. The company have proudly announced the first regulatory approval for a donor derived microbiome drug product worldwide.
The Role
Reporting to the Chief Operations Officer, 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.
You will be responsible for:
* 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 published
You will bring to this role:
* 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, solid understanding on how to obtain key answers when issues aren’t directly addressed
* 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
* Be a crucial leader within a dynamic and multi-cultural team, fostering a great culture and values: Openness, Quality, Innovation, Communication, Solution oriented
How to Apply
Join a close-knit, passionate and innovative team at the forefront of microbiome research and working with novel therapies!
If you have the skills and experience to excel in this position and you are looking to join an exciting organisation within a growing industry apply now. Please note only shortlisted candidates will be contacted.