Director Regulatory Affairs, Europe
Rare Disease Biologics
EMA Filings Experience Required
Remote position- time in HQ in Europe will be required for business critical requirements.
** Please note candidates must live in Belgium to be considered **
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 Director EU Regulatory Affairs to support on a number of new indications, from early to late phase development & lifecycle management. You will report into the Head of Regulatory Affairs, Europe & International Markets.
About the Role
This role is an exciting opportunity to join as a key member of the EU & International regulatory team and will be working on a number of indications spanning early & late phase development, and lifecycle management. This will include providing hands-on contributions to MAAs across Europe, including EMA, MHRA and Swiss Medic. 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 MAA filings to the EMA.
* EMA experience is required, additional experience with MHRA or Swiss Medic would be beneficial.
* Experience in orphan drugs or novel first-in-class/ best-in-class indications would be highly beneficial
* Pharma or biotech experience is required, any experience in rare disease & unmet medical need 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.