Expiry Date: 09-05-2021
Category Regulatory Affairs
Job Type: Full Time
REGULATORY ** 2 of a Kind! ** Global and EU Regulatory Leaders / Liaisons ***Oncology, Haemo or Rare Diseases * W London / NW Home Counties
Note on Covid & Location: this major R&D-based, top 5 bio-pharma, has established remote working during Covid which will last well beyond December 2020, possibly into Summer 2021. Interviews will be conducted by Video and you will be able to be on-boarded from your home. Relocation is of course on offer if you require it but this can be held over and delayed ‘til Summer 21.
The company will buyout stock and loss of bonuses for the right individual!
About My Client
This is a US giant R&D pharmaceutical company, but, they differ from other top 5 and top 10 companies because the organization is agile, the line management highly available and engaged, and they have happily not implemented the common practise of line managers not being involved in therapy area management so your manager, has the actual experience and track record in filings to be useful to your growth and help you with successfully navigating the regulatory hurdles.
What I like about these 2 roles are you will run straight into a pre-submission process, so you will not be left wanting if you want MAA/NDA/s/NDA filings, and do not want to wait 3 years to receive it!
Two of a Kind!
We have 2 of a kind vacancies, the first is for a Global Regulatory Leader and the second is for an EU Regulatory Leader / EU Liaison, both are for accomplished individuals with at least first MAA/ NDA experience or for 2-3 major label expansions or new indications with approvals.
How do the 2 roles differ?
The Global Regulatory Leader is for an existing GRL, or for an individual who has been exposed to the US regulatory framework, sat in on many meetings with the US RL, and worked behind the scenes to align EU and US regulatory strategy, even if you were just influencing thinking. If you have these two levels of experience, this qualifies you to consider this position.
You will consider yourself a high performer, you will internally push yourself forward, and want to work in a high dynamic, fast paced environment, where you will collaborate / sit with the Clinical team on the one side, and the Regulatory SubTeam on the other, and what’s more this is for one of the best assets my client has, which will benefit from an accelerated filing (soon).
The EU Regulatory Leader / Liaison, is for an individual who wants a high succession of filings in any given period, where you will take NMEs and existing assets, from either Phase 2 to Phase 3 and file, or from 3b to file, you will have oodles of Scientific Advice and Pre-Subs meetings to prepare for, with ANSM and EMA most likely, as well as MAA preparations, and the review lifecycle.
I would say this role is best described as focusing on ‘new lifecycle’, i.e. multiple new indications, and label expansions, of course, if you do well, you can move into team management or a global strategy role in time based on merit and interest (my last placement in this group prefers staying at the project level and enjoys this, another has recently taken on a big team in early development).
Package & Salary
Are superb! Both roles have bandwidth on grading, i.e. Associate Director or Director, but this company is definitely in the upper quartile of compensation and benefits, have a strong performing RSU-based Share package, strong bonus, and relocation if needed. In most countries, either a car or car allowance are provided!
The company will buyout existing stock and loss of bonus, so if you want a high-visibility, high levels of filing type of environment, with the molecules having a decent probability of regulatory success, then please do not wait for your bonus next year, as we can accommodate!
To apply for this role, please contact Theo Moore or Matt Greig on +44.207.801.3384/6 - alternatively, please send a full CV to firstname.lastname@example.org and we will reply by return. We do take calls after hours ‘til 8.30 CET and Saturday / Sunday AMs by calling +447918679405.
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