Regulatory CMC Director *** Biologics Development *** Global Role (US, EU, Japan, China) *** Great Package *** Remote (if on the West Coast)

Reference: KLT2207

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: HQ on Upper West Coast, but this position can be fully remote.

 

“This role will suit you if you enjoy having full responsibility and leadership for your projects, if you enjoy offering solutions and pathways, and enjoy the variety of activities that comes with a varied pipeline and global submissions.”

We have an interesting and expansive new Regulatory CMC Director level role where you will be responsible for the delivery of CTA/IMPD’s and MAA/NDA/BLA submissions to global Health Authorities, with independent responsibility for Regulatory CMC strategic & operational decisions for several investigational monoclonal antibody products and a newly registered NME where there are plans to register into Japan and China in 2023.

My client is quite unique, they have a European heritage and have over 5000 employees in more than 40 countries, and their products are registered in over 100 countries and over 45 million patients world-wide. They are highly regarded by their own staff (and described online as a great place to work by 90% of their employees) and offer benefits and holiday allowances in line with Europe, so way higher than the norm in the US market.

The Leadership Team is very supportive and understanding as well as willing to act on stepwise changes or appropriate initiatives that could be required to enable better ways of working for the CMC Regulatory workstream. The organization invests a healthy 20 plus percentage wise in R&D budget yearly, has a stable stock listing and has little debt.

The HQ is based on the upper West Coast, but my client is happy with this position, at this level to be remote, with occasional visits to the HQ to help build and aid stakeholder relationships.

PTO, holidays, and company culture are rated very highly and much stronger and more generous than most US organisations. The culture is based on respectful stakeholder interaction and engagement, and it’s expected that employees have a major input around shaping working procedures. Package and benefits are within market norms, and the company will consider buying out stock plans and bonus losses for the right individual.

 

To Apply!

To apply for this role or if you are interested in discussing the role in more detail, in the first instance please, contact me Theo Moore on 908.348.6714 – I am available and happy to speak daytime or early evenings and also Saturday / Sunday mornings, or please send a full CV in confidence on Theo@AdvTalent.com or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!

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