Expiry Date: 03-05-2021
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Global Regulatory Director, reports to PL (mAb, EOP2 / global RA strategy role)
Location: Brussels, Belgium
About the Opportunity
This is a role with a mid-sized biopharma company with 4 or so therapy areas and with a long track record of bringing new medicines to market. This is not a top 5 or top 10 pharma company, but leaner, smaller, and more agile.
The role is a Global Strategy Lead so you will take an EOP2 asset through Ph 3 and into BLA, and lead the regulatory sub team through to parallel submissions in all the core markets, and for the first wave of the international majors. Uniquely, this role reports to the PL, so you will be based in the same site as the PL and work directly in his team.
The client would like an individual who has been a GRL before, so this means, you might have led a s/NDA or NDA (but where the local sub was done by your US liaison), or you have been highly exposure to US framework, and know the US pathway well.
You will be a focused individual, who lives and breathes drug development, the vision you have for your molecule and know how to balance risk with innovation.
About the Molecule
The NME is a mAb, in a disease area which is highly debilitating and as yet, not properly met with treatment options.
Package & Relocation
You want to benefit from a stock and bonus package, which keeps you engaged and also a career path which keeps you on your toes in a positive way! My client offers RSU based stock, car allowance and performance bonus, and will entertain buying out existing bonus / stock plans (within reason). They offer a full relocation subject to their policy if you want to move to be near the site.
Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
To apply for this role, please press the red “Apply for position” button, or contact Theo on +44 (0)207 801 3384 or Oli on +44 (0)207 801 3388 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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