Expiry Date: 29-06-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory Associate Director ** EU Strategy Lead ** W London, UK
This is a pedigree company offering the opportunity for an experienced Senior Regulatory Manager or RA Project Manager to step upto Associate Director as long as you can show examples of strategy development as well as MAA or Line Extension submissions.
My client has grown substantially in the last few years and are now nearing the top 5 of global R&D based companies, but unlike other US and top 5 companies, they are known for being non-hierarchical, a matrix-led decision-making environment where individuals in regulatory can progress quickly based on merit and effort, these are highly rewarded.
The role is to lead the development of NMEs in Ph 1-3, for the EU region, in a company where evolving the EU RA strategy, Scientific Advice, Pre-submission meetings and the label negotiations with Health Authorities are very much in your domain. The NMEs are not ‘me too’ so they are novel, 1st in Class, high patient value assets (this is a company which has more than several blockbusters) and one where the science, and how to translate this into a clinical value and regulatory dossier, are part of the culture and approach the regulatory teams live and breathe.
The company is financially very stable, has the ability to finance pivotal studies per NME in parallel for multiple indications, as well as license in new technologies and NMEs at a very rapid rate. The company is widely acknowledged as being one of the most active in this area in the recent years.
There are 2 new roles are now available due to expansion not replacements, for you to apply for. The company offers a car or car allowance, bonus and stock plan, as well as an attractive salary package (certainly, they are in the upper quartile). The company will buy out stock or bonus losses for the right person.
To apply for this role, please press the red “Apply for position” button, or contact me Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
Note on Covid & Location: this major R&D-based, top 5 bio-pharma, has established remote working during Covid which will last possibly into Summer 2021. Interviews will be conducted by Video and you will be able to be on-boarded from your home.
We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.
GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.