Executive Director Regulatory CMC – Global, pure Cell & Gene Therapy - Team Mngt – East Coast OR Remote Working

Reference: MG10587F

Expiry Date: 23-06-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

New Haven County
United States

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Job Description

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:-

  • Managed people and has direct line management experience of small or larger teams
  • Highly educated, with bio-engineering and biochemistry type degree
  • Track record, must have led for CMC RA filings and submissions, and have experience of adeno or lenti VVs, or filed another new modality and has educational or research experience in VVs to augment experience with
  • Has direct US experience and a good understanding of the EU regulations for ATMPs and biologicals; has supported MSAT and CMC sub teams through the CMC development pathway ideally regulatory and scientific input including Ph 3 scale up and BLA requirements
  • Is a collegiate team player, and team motivator who manages with flair and supports the senior LT grow and develop the overall regulatory platform
  • Can instigate new systems and processes and has taken co-led / co-hosted a PAI.


To Apply!

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.

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