Expiry Date: 23-06-2022
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
This is a superb opportunity for an experienced Cell & Gene Therapy CMC Regulatory expert to move into a leadership role for a pipeline with several NMEs in clinical development.
You will be joining a function led by a Global Head and SVP of Regulatory Affairs who we have known for the last 15 years, heading up a highly tipped innovator and biotech in their growth phase, with offices and R&D sites in the East Coast and West Coast USA.
This is not a mega pharma but they already have registered 4 new molecules in major markets, so we are looking for someone with has a pioneering spirit but also wants to build on their existing successes, grow and develop the RA CMC team and develop / foster the new modality drugs in the pipeline (half of which are moving into late phase development).
This role is to join and lead their existing regulatory CMC team to manage several assets which are ATMP / new modality products based on Viral Vectors, and Oligos based on the East Coast. There is an opportunity to work remotely (East Coast or Central time zone) but you will attend site regularly.
The company has 1 Billion USD in cash to help foster their drugs, into registration, and are led by a senior LT which has a very decent reputation. They are mid-way through market launches and new market entries world-wide (their turnover is growing rapidly).
The portfolio is definitely aimed at the rare diseases and orphan specialty segments.
You will lead a global group of 5-8 FTEs with both US and global responsibility for all NMEs in Ph 1 to 3, regulatory CMC input into Ph 3 scale up, pre-BLA build and BLA / EU MAA submissions for QoS and M3, as well as for eventual lifecycle. This will include CMC queries, FDA meetings and responses, EU Scientific advice, as well as for networking and policy involvement on a topical level.
The role is open to a Senior Director or Director who has:-
To apply for this role, please contact me Theo Moore on US 908-348-6714, alternatively, please send a full CV to me in confidence on Theo@AdvTalent.com and I will reply by return.
We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number 908-348-6714.
GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.