Director Regulatory Affairs CMC *** Small Team – Global Role – Lead a BLA and expansion into Japan and China *** Remote (HQ in Upper West Coast) ***

Reference: KLT2207A

Expiry Date: 18-10-2022

Categories Biotech, Manufacturing / Production, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
King County
Съединени щати
Remote Working

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Job Description

Location: Remote, with the Global HQ in Upper West Coast.

“This role would suit someone that wants to work in smaller team with less hierarchy and more focus on innovation and strategic leadership!”

We think this is a great role for a company with an exciting pipeline, and great plans for expansion – 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.

This is currently a small team, but this position will be the first piece of the expected growth of the Regulatory CMC Biologicals department. So, as well as taking a leading role as the Regulatory CMC Director for indications in development and planned NDA’s 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.

As the Regulatory Director CMC, you will be responsible for managing the Regulatory CMC aspects of assigned projects in early to late-stage development, as well as overseeing the global expansion of a recently approved biologicals product fresh to the market in 2022.  This is a wide and varied role including everything from strategy oversight and HA interactions to helping to formalize submission processes and development roadmaps.

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.

On offer is a great overall package including high level and very generous PTO, extensive benefits and a very competitive salary and bonus structure.  The working culture is relaxed and focused on strong and positive inter-department/cross functional interactions.

We think this is an exciting role for an impressive organization and in the first instance, if you are interested in applying or discussing the role in more detail, please call me, Theo Moore on 908.348.6714 (incl. early evenings and Saturday / Sunday mornings) or please send a full CV in confidence on Theo@AdvTalent.com.

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