Expiry Date: 22-11-2022
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Département de Paris
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 its regulatory HQ hub in London and is open to hire in their affiliate site in Paris 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:
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 basic salary, bonus and company benefits.
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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