Regulatory Affairs Director CMC, Biologics *** Remote *** BLA’s and Global submissions *** Great Package!

Reference: KLT2707

Expiry Date: 03-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

King County
Съединени щати
Remote Working

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Job Description

“We think this is a great role for a company with an exciting pipeline, and great plans for expansion!”

Location: Remote (Global HQ on the West Coast)

This is a unique opportunity to join an established (50 years old) Bio/Pharma now expanding and developing its Biotech portfolio. My client is looking for someone with a collaborative and team-oriented attitude, who can foster effective and positive interactions across functions, project teams, regulatory agencies as they start down the road of growing their new Regulatory CMC Biologicals team.

So, as well as taking a leading role as the Regulatory CMC Director for indications in development, and planned NDAs into Japan and China in 2023, you will also be setting the structure for the growth of a new team to follow this year and next. This is currently a small team but set to grow and the role will be the first piece of the expected growth of the CMC biologicals team.

You will be reporting into a strong and dedicated VP of Regulatory CMC who will be working with you to help shape and grow the new team build. The Regulatory Leadership team is well established and well respected, with many coming from the Top Ten Biotech companies on the West Coast.

This is a global role, initially as an owner contributor, but opportunities for management, mentoring and/or team leading will be available in the future, as my client has a strong pipeline that continues to expand and thrive, and the regulatory teams continue to grow and grow.

On offer is a great overall package including high level and very generous PTO and benefits with very competitive salary and bonus structure.

There is a great package on offer and full flexibility to work remotely.

Please contact Theo Moore on US +1-908.348.6714 or via email at and I would be happy to discuss the role further and give you more information

If this role isn’t quite for you but you are open to something new, I would be happy to discuss other roles we have open.


To Apply!

To apply for this role, please contact me Theo Moore on US 908.348.6714 or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!

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