EU Regulatory Director ** Lead a Mega Brand for Lifecycle - CV / Respiratory / Metabolism (C)

Reference: JM10591C

Expiry Date: 02-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Département de Paris
France

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Job Description

Location:  this role can be based in NW London / NW Home counties or in Switzerland. The role comes with a full relocation package both in the UK and to Switzerland.

My client is a well-known R&D based pharmaceutical company with drugs in development across ADCs, mAbs, NCEs, and Cell & Gene therapies. This is a large pharmaceutical company, but the therapy teams are smaller, close-knit and highly involving and supportive! Hybrid working is available!

This is a regulatory strategy lifecycle leading role for someone at Director or Associate Director level, who wants to manage a drug with a value of several Billion USD per year. The drug has further clinical trials running, and you will manage 1-2 NMEs in Ph 1/2 at the same time.

You will be the EU Liaison and EU Regulatory Strategy Leader for this position, and be working with both the US, and affiliates, clinical and commercial, so you will be someone who knows how to give the regulatory options a voice, align with senior people, and drive the teams to deliver the submission plans.

You will concurrently look after a development compound, so in this role you will help evolve EU strategy (the company normally assigned a GRL late Phase 2) and oversee any Scientific Advice meetings, manage the regulatory plan (CTAs are coordinated by another team, so oversight only) and help develop the EU part of the TPP.

My client thinks it is important you have  foot in both development and lifecycle, and as the brand becomes quieter, you will take on more projects in the development space.

What we are looking for?

You will have managed a big brand in either lifecycle or new lifecycle, with a high value, and be used to working with strong minded commercial people as well as with global, to align and hone EU strategies. You will have experience in HA negotiations, matrix management or direct, and know how to press a few levers to get things done!

What is my client offering?

The role comes whether based in London or Switzerland a high end package, annual stock and bonus award which can be performance weighted (it has good multipliers) and they offer car and health insurance in both countries.

 

To Apply!

To apply for this role, please contact me, Matt Greig or my colleagues Javier Monfort and Christian on UK +44(0) 207 801 3386 or press the red “Apply for position” button, or send a full CV to CV@advtalent.com. We will support you throughout the interview and on-boarding experience.

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