Head Regulatory Affairs, Early Development Pipeline
Rare Disease
Early Phase Filings Experience Required
Location- Remote in the US, candidate must live in east coast time zone (or be willing to relocate themselves there)
Travel- time in HQ in Europe will be required for first few months, then this can drop down to once a quarter/ business critical requirements.
About the Company
We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which are now launching into further markets around the world. The portfolio ranges from preclinical to approved products, with multiple new indications currently being explored. We are looking for a Head of Regulatory Affairs, Early Development to support the rapid growth needed to support in the early pipeline. You will report to the Global Head of Regulatory Affairs.
About the Role
This role is an exciting opportunity to join as a key member of the global regulatory leadership team. You will be responsible for implementing global regulatory strategies for studies through to the end of phase I / first in human/ proof of concept. You will lead the early phase regulatory team, and be a member of the early phase disease area committee, working on the design & conduct of FIH & proof of concept studies for new programs.
We are looking for candidates who have the below experience:
- Experience of working on regulatory strategy for early phase compounds (this must include phase I trials in healthy volunteers), this will ideally include successful filings such as INDs and CTAs.
- Global regulatory filing experience must include US & Europe, additional experience in other markets such as Canada would be beneficial
- Pharma or biotech experience is required, any experience in rare disease, unmet medical need or innovative medicine would be advantageous
- Strong knowledge in early stage drug development & the biopharma regulatory landscape
- A willingness to work operationally and "hands-on" when required to get tasks completed
- A desire to work in a biotech environment which can be fast-paced & demanding, whilst also being able to adapt to any strategic changes in pipeline direction.
Please apply with an up to date CV for consideration.