Regulatory CMC Associate Director *** MA or Remote *** Modified Release ** Help a Director develop strong lifecycle mngt for existing Blockbuster Chem Entities and Oligos!

Reference: NBU542

Expiry Date: 03-05-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Suffolk County
United States
Remote Working

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Job Description

My client has consistently bucked the trend and is one of the profitable and successful biotechnology companies existing today, and what is a little known fact, is this household name has both a stable of small molecule products (47% of R&D) not just a stable of blockbuster biologicals.

This team has expanded last year, to manage a plethora of lifecycle strategies and is continuing to hire, hence this newly created role, for an Associate Director of RA CMC Small Molecule, to lead one or two products globally (you will have US experience as a minimum) but note, in a company where some of the heavy lifting is done by a CRO’s Alliance team, and who also manage some of the countries (ASEAN) giving you the time to focus on developing and shaping strategy.

The main deliverables apart from managing in matrix Sr Managers to deliver your VARs and Updates is more controlled / sustained release line extensions, the company wants to use their clinical data to effect better dosing through line extensions and this is a big franchise, multi-billion USD in terms of size. The team is around a dozen people and led by a successful Head of, but you will report to a new person who we found the client end of last year (ex Roche / Genentech).

We would be happy to talk to you about the role, why we think it will help you develop your career and what the company will do to enhance your technical and leadership skill sets?

Package & Benefits

The company will consider buying out stock and bonuses for the right person. This role comes with a US package, including decent bonus and multipliers as well as a stock plan which starts vesting on 1st year anniversary and Options. The company are known for their diversity and inclusion and their overall company Chair for this who is actually in CMC Regs!


You can be fully remote, anywhere in East Coast, Mountain Time, Central Time with irregular visits to office which are funded alternatively you can be based in NC or MA which are closer to their hubs!


To Apply!

To apply for this role, please contact me, Christian or my colleague Matt Greig on US 908 332 9175 or press the red “Apply for position” button or send a full CV to and we will reply immediately to explain more about our client and the role. We know the hiring manager and the leadership team so we will support you throughout all the interviews and on-boarding process.

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