Senior Director Regulatory Affairs, Asset Lead
Rare Disease
BLA & MAA Filings Experience Required
Location- Remote in Belgium, Switzerland or East Coast of US
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 Senior Director Regulatory Affairs, Asset Lead to support the rapid growth in a late phase asset with multiple indications. 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 and will be working on a late stage asset that is preparing for its first global marketing application. The role provides a critical contribution to the development of product regulatory strategies for different indications and will be a key advisor and enabler of successful product launches and commercialization activities.
We are looking for candidates who have the below experience:
- Experience of working on regulatory strategy for late phase compounds- this must include successful filings such as BLAs and MAAs.
- US FDA and EMA experience is required, additional experience with PMDA Japan would be beneficial.
- Experience in neuromuscular disease & autoimmune conditions would be highly beneficial
- Pharma or biotech experience is required, any experience in rare disease, unmet medical need or innovative medicine would be advantageous
- Strong knowledge in overall 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.