Expiry Date: 30-04-2024
Job Type: Full Time
Do you want to be autonomous in your work and interact closely with the leadership team, to have higher visibility and more opportunities to grow …… then this could be the role for you!
We would like to introduce you a fresh role for an Associate Director Regulatory Affairs in progressive, smaller (but well-funded) Biotech, with their own vectoring and discovery platform and has various RNA modes including a very novel editing approach being led by an impressive senior executive leadership team. They are stable and has a long funding horizon in excess of 2 years + before milestone payments. The culture is very warm and welcoming and in the same time the team is highly strategic and creates entrepreneurial, smart, collaborative and supportive environment.
Our client company is recruiting a Regulatory Affairs professional with experience in managing and leading global clinical trials and regulatory submissions, having EU experience and late phase to filing would be superb but not mandatory.
About the role:
In this role you will be working on early and mid-phase compounds, in rare diseases, obesity and liver / pancreas as well as lung. This is a regulatory development role, so you will be part of the preparation of written procedure and face to face Scientific Advice meetings, CTA/IND annual and safety updates and IND amendments and ODDs. If everything goes well, their first full submission at BLA / MAA will be in the next 18-24 months.
Location and package:
The role is based in the Boston area and comes with strong package which includes Stock on joining, as well as performance bonus and decent health insurance.
Please send me a message or a copy of your resume to my personal email: Christian@AdvTalent.com or call me or my senior colleague Matt Greig at 908.332.9157 - I look forward to speaking to you!