2 x RA CMC positions: Director CMC RA & Associate Director ** NCEs ** Pure Dev roles ** Hybrid ** The Netherlands

Reference: ISM515B

Expiry Date: 22-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Amsterdam
Нидерландия

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Job Description

About These New Roles & Opportunities

The company is very sound in their business approach, smaller than most, and the team is close knit, friendly and helpful. You will be hired in these newly created roles to support their late phase pipeline, so Ph 2/3 IMPDs, MAA preparation for M2/3. 

My client has a regulatory hub in both London and Amsterdam, and are now hiring to support New Chemical Entities in Phases 2 and 3 and soon, pre-sub, for anti-infectives and new drugs in rare diseases. What I like about this company and the roles is:

  • They offer a friendly atmosphere, they are collegiate, respectful, and established team of a dozen or so; the senior LT are informal, and talk to / connect with everyone in the offices
  • These two roles have primarily a development focus, so you won’t be working on mature products or lifecycle (you will support after your first MAA approvals, line extensions for the new products you will register down the road)
  • This is a SME R&D company with EU Marketed products so they are financially stable, they are a global R&D-based pharma but smaller than Big Pharma or other companies in the NL
  • They are not a start-up, and have established processes and support, to help you build your MAA M3s, in a company which I would describe as having low political noise and this teams focus is on EU MAA CMC submissions
  • You want to work for an Executive Director who has a real track record of preparing and filing MAAs in Europe for NMEs and has a lot of experiences to share to help guide your success in this smaller, more agile global pharma.

Director Regulatory CMC NCEs New Projects

The more senior role is a Director of RA CMC who has matrix management experience and can lead a NCE into M3 build and submission for the EU and selected international countries. You will have previous matrix or line management experience and have led a MAA build for QoS and M3. You will have a friendly disposition, and now how to encourage your matrix team, and manage expectations with stakeholders, ensure CMC RA risk mitigation, planning and support to the Therapy Regulatory Lead during final submission and review periods.

Associate Director RA CMC NCEs New Projects

This role will support the more senior role, and you will have IMPD and MAA QoS and M3 build experience and be prepared to lead sub projects for a filing in preparation under the guidance and support of the Director and Head of RA CMC.

Both of these roles are working in small molecule drug development, so we would like to invite you to apply if you feel comfortable with working on CMC M3 for late phase compounds and can demonstrate a track record in MAAs or major Line Extensions, IMPDs, for innovator products.

Location and Benefits

This client allows home working most of the time, depending upon your situation, and would not ask you to be in the office more than 1-2 days maximum per week, The roles come with a decent Bonus and company benefits.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Christian Atanasov +44(0) 207 801 3382, or my colleague Javier Monfort on +44(0) 207 801 3385 or send a full CV to CV@advtalent.com and we would be happy to discuss the role further and give you more information. As we know the hiring manager, we will support you throughout the interview and on-boarding experience.

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